Trial Outcomes & Findings for Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer (NCT NCT04865731)
NCT ID: NCT04865731
Last Updated: 2025-08-06
Results Overview
Number of radiation dermatitis adverse events defined by the NCI CTCAE version 5 that are graded as 2 or higher
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
15 months
Results posted on
2025-08-06
Participant Flow
Participant milestones
| Measure |
Dermaprazole
HNC patients who will be using Dermaprazole twice daily for 7 weeks
Dermaprazole: Patients will be managed with twice daily prophylactic use of the proposed intervention (Dermaprazole) topical cream for radiation dermatitis. The amount of cream will be 2cc per application and will be measured in pre-filled capped syringes for every application.
|
Aquaphor
HNC patients using Aquaphor, the current clinical standard of care
Aquaphor: Patients will be managed with twice daily prophylactic use of Aquaphor. The amount of Aquaphor will be 2cc per application and will be measured in pre-filled capped syringes for every application.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Dermaprazole
HNC patients who will be using Dermaprazole twice daily for 7 weeks
Dermaprazole: Patients will be managed with twice daily prophylactic use of the proposed intervention (Dermaprazole) topical cream for radiation dermatitis. The amount of cream will be 2cc per application and will be measured in pre-filled capped syringes for every application.
|
Aquaphor
HNC patients using Aquaphor, the current clinical standard of care
Aquaphor: Patients will be managed with twice daily prophylactic use of Aquaphor. The amount of Aquaphor will be 2cc per application and will be measured in pre-filled capped syringes for every application.
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Dermaprazole
n=4 Participants
HNC patients who will be using Dermaprazole twice daily for 7 weeks
Dermaprazole: Patients will be managed with twice daily prophylactic use of the proposed intervention (Dermaprazole) topical cream for radiation dermatitis. The amount of cream will be 2cc per application and will be measured in pre-filled capped syringes for every application.
|
Aquaphor
n=2 Participants
HNC patients using Aquaphor, the current clinical standard of care
Aquaphor: Patients will be managed with twice daily prophylactic use of Aquaphor. The amount of Aquaphor will be 2cc per application and will be measured in pre-filled capped syringes for every application.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
6 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 15 monthsNumber of radiation dermatitis adverse events defined by the NCI CTCAE version 5 that are graded as 2 or higher
Outcome measures
| Measure |
Dermaprazole
n=4 Participants
HNC patients who will be using Dermaprazole twice daily for 7 weeks
Dermaprazole: Patients will be managed with twice daily prophylactic use of the proposed intervention (Dermaprazole) topical cream for radiation dermatitis. The amount of cream will be 2cc per application and will be measured in pre-filled capped syringes for every application.
|
Aquaphor
n=2 Participants
HNC patients using Aquaphor, the current clinical standard of care
Aquaphor: Patients will be managed with twice daily prophylactic use of Aquaphor. The amount of Aquaphor will be 2cc per application and will be measured in pre-filled capped syringes for every application.
|
|---|---|---|
|
Rates of Clinically Significant Radiation Dermatitis as Defined as NCI CTCAE Version 5 Grade 2 or Higher
|
3 Number of events
|
1 Number of events
|
Adverse Events
Dermaprazole
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Aquaphor
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dermaprazole
n=4 participants at risk
HNC patients who will be using Dermaprazole twice daily for 7 weeks
Dermaprazole: Patients will be managed with twice daily prophylactic use of the proposed intervention (Dermaprazole) topical cream for radiation dermatitis. The amount of cream will be 2cc per application and will be measured in pre-filled capped syringes for every application.
|
Aquaphor
n=2 participants at risk
HNC patients using Aquaphor, the current clinical standard of care
Aquaphor: Patients will be managed with twice daily prophylactic use of Aquaphor. The amount of Aquaphor will be 2cc per application and will be measured in pre-filled capped syringes for every application.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
2/4 • Number of events 3 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
50.0%
1/2 • Number of events 5 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
|
Gastrointestinal disorders
Anorexia
|
25.0%
1/4 • Number of events 8 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
0.00%
0/2 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
50.0%
1/2 • Number of events 1 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
|
General disorders
Dehydration
|
25.0%
1/4 • Number of events 3 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
0.00%
0/2 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
|
Skin and subcutaneous tissue disorders
Dermatitis radiation
|
100.0%
4/4 • Number of events 11 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
100.0%
2/2 • Number of events 5 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
|
Gastrointestinal disorders
Anosmia
|
25.0%
1/4 • Number of events 1 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
0.00%
0/2 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
|
Gastrointestinal disorders
Dry mouth
|
75.0%
3/4 • Number of events 21 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
100.0%
2/2 • Number of events 5 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
|
Gastrointestinal disorders
Dysgeusia
|
100.0%
4/4 • Number of events 14 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
50.0%
1/2 • Number of events 2 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
|
Gastrointestinal disorders
Dysphagia
|
75.0%
3/4 • Number of events 18 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
50.0%
1/2 • Number of events 1 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
|
Ear and labyrinth disorders
Ear and Labyrinth disorders
|
50.0%
2/4 • Number of events 6 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
0.00%
0/2 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
|
General disorders
Fatigue
|
100.0%
4/4 • Number of events 10 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
50.0%
1/2 • Number of events 3 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
|
General disorders
Hoarsness
|
50.0%
2/4 • Number of events 2 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
0.00%
0/2 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
|
Blood and lymphatic system disorders
Lymphedema
|
50.0%
2/4 • Number of events 2 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
50.0%
1/2 • Number of events 1 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
|
Gastrointestinal disorders
Mucositis oral
|
100.0%
4/4 • Number of events 12 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
100.0%
2/2 • Number of events 8 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
|
Immune system disorders
Myelitis
|
25.0%
1/4 • Number of events 1 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
0.00%
0/2 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
4/4 • Number of events 15 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
100.0%
2/2 • Number of events 5 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
25.0%
1/4 • Number of events 1 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
0.00%
0/2 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
25.0%
1/4 • Number of events 1 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
50.0%
1/2 • Number of events 2 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
|
Gastrointestinal disorders
Oropharyngeal pain
|
25.0%
1/4 • Number of events 5 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
0.00%
0/2 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
25.0%
1/4 • Number of events 2 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
0.00%
0/2 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
100.0%
4/4 • Number of events 16 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
50.0%
1/2 • Number of events 1 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
|
Gastrointestinal disorders
Trismus
|
0.00%
0/4 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
50.0%
1/2 • Number of events 5 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 4 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
0.00%
0/2 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
|
Gastrointestinal disorders
Weight loss
|
75.0%
3/4 • Number of events 15 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
50.0%
1/2 • Number of events 3 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
0.00%
0/4 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
50.0%
1/2 • Number of events 1 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased
|
0.00%
0/4 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
50.0%
1/2 • Number of events 2 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
0.00%
0/4 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
50.0%
1/2 • Number of events 4 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/4 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
100.0%
2/2 • Number of events 4 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
|
General disorders
Hypercalcemia
|
0.00%
0/4 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
50.0%
1/2 • Number of events 1 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/4 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
50.0%
1/2 • Number of events 1 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
|
Blood and lymphatic system disorders
White Blood Cell decrease
|
50.0%
2/4 • Number of events 8 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
50.0%
1/2 • Number of events 5 • Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short \& long-term (greater than 6 month) skin changes.
|
Additional Information
Dr. Shraddha Dalwadi
University of Texas Health Science Center at San Antonio
Phone: 210-567-1203
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place