Trial Outcomes & Findings for Supersaturated Calcium Phosphate Rinse in Preventing Oral Mucositis in Young Patients Undergoing Autologous or Donor Stem Cell Transplant (NCT NCT01305200)
NCT ID: NCT01305200
Last Updated: 2019-09-17
Results Overview
Mean days of severe (WHO Grade 3 or 4) Mucositis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
226 participants
Primary outcome timeframe
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Results posted on
2019-09-17
Participant Flow
Participant milestones
| Measure |
Arm I (Placebo)
Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
Arm II (Supersaturated Calcium Phosphate Rinse)
Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
Arm III (Enrolled But Not Randomized)
Site not randomized
|
|---|---|---|---|
|
Overall Study
STARTED
|
111
|
112
|
3
|
|
Overall Study
COMPLETED
|
82
|
81
|
0
|
|
Overall Study
NOT COMPLETED
|
29
|
31
|
3
|
Reasons for withdrawal
| Measure |
Arm I (Placebo)
Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
Arm II (Supersaturated Calcium Phosphate Rinse)
Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
Arm III (Enrolled But Not Randomized)
Site not randomized
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
4
|
6
|
1
|
|
Overall Study
Withdrawal by Subject
|
24
|
21
|
1
|
|
Overall Study
Ineligible
|
1
|
2
|
1
|
|
Overall Study
Death
|
0
|
2
|
0
|
Baseline Characteristics
Supersaturated Calcium Phosphate Rinse in Preventing Oral Mucositis in Young Patients Undergoing Autologous or Donor Stem Cell Transplant
Baseline characteristics by cohort
| Measure |
Arm I (Placebo)
n=111 Participants
Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
Arm II (Supersaturated Calcium Phosphate Rinse)
n=112 Participants
Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
Arm III (Enrolled Not Randomized)
n=3 Participants
Site not able to randomize.
|
Total
n=226 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
12.75 years
STANDARD_DEVIATION 5.05 • n=99 Participants
|
13.02 years
STANDARD_DEVIATION 4.54 • n=107 Participants
|
12.00 years
STANDARD_DEVIATION 1.73 • n=206 Participants
|
12.88 years
STANDARD_DEVIATION 4.79 • n=7 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
104 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
122 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
55 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
82 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
163 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
6 Participants
n=7 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
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
87 Participants
n=99 Participants
|
82 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
172 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
|
Region of Enrollment
Canada
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
105 Participants
n=99 Participants
|
102 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
210 Participants
n=7 Participants
|
|
Region of Enrollment
Australia
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Region of Enrollment
Puerto Rico
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.Population: Evaluable patients defined as patients with \>= 11 daily WHO assessments.
Mean days of severe (WHO Grade 3 or 4) Mucositis.
Outcome measures
| Measure |
Arm I (Placebo)
n=91 Participants
Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
Arm II (Supersaturated Calcium Phosphate Rinse)
n=91 Participants
Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
|---|---|---|
|
Duration of Severe Oral Mucositis (WHO Grade 3 or 4)
|
4.5 Number of days
Standard Deviation 4.8
|
4.5 Number of days
Standard Deviation 5
|
SECONDARY outcome
Timeframe: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.Population: Evaluable patients defined as patients with \>= 11 daily WHO assessments.
Percentage of patients with Severe Oral Mucositis (WHO Grade 3 or 4) per arm.
Outcome measures
| Measure |
Arm I (Placebo)
n=91 Participants
Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
Arm II (Supersaturated Calcium Phosphate Rinse)
n=91 Participants
Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
|---|---|---|
|
Incidence of Severe Oral Mucositis
|
68 percent of patients
|
63 percent of patients
|
SECONDARY outcome
Timeframe: Day -1 (day prior to stem cell infusion) to Day 20 following transplantationPopulation: Evaluable patients defined as patients with ≥11 daily WHO assessments.
Area under the curve (AUC) of the Oral Mucositis Daily Questionnaire (OMDQ) subscales
Outcome measures
| Measure |
Arm I (Placebo)
n=91 Participants
Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
Arm II (Supersaturated Calcium Phosphate Rinse)
n=91 Participants
Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
|---|---|---|
|
Oral Mucositis Daily Questionnaire (OMDQ)
Sleeping
|
9.3 units on a scale * day
Standard Deviation 10.9
|
7.3 units on a scale * day
Standard Deviation 9
|
|
Oral Mucositis Daily Questionnaire (OMDQ)
Mouth and Throat Pain
|
22.3 units on a scale * day
Standard Deviation 14.8
|
21.4 units on a scale * day
Standard Deviation 14.7
|
|
Oral Mucositis Daily Questionnaire (OMDQ)
Swallowing
|
21.4 units on a scale * day
Standard Deviation 15.7
|
19.9 units on a scale * day
Standard Deviation 15.9
|
|
Oral Mucositis Daily Questionnaire (OMDQ)
Drinking
|
21.7 units on a scale * day
Standard Deviation 16.3
|
20.6 units on a scale * day
Standard Deviation 17.3
|
|
Oral Mucositis Daily Questionnaire (OMDQ)
Eating
|
27.9 units on a scale * day
Standard Deviation 19.4
|
26.6 units on a scale * day
Standard Deviation 20.7
|
|
Oral Mucositis Daily Questionnaire (OMDQ)
Talking
|
12.2 units on a scale * day
Standard Deviation 11.5
|
12 units on a scale * day
Standard Deviation 13.2
|
SECONDARY outcome
Timeframe: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.Population: Total of 210 patients evaluable for this assessment (106 Arm I \& 104 Arm II)
Opioid Administration = yes
Outcome measures
| Measure |
Arm I (Placebo)
n=106 Participants
Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
Arm II (Supersaturated Calcium Phosphate Rinse)
n=104 Participants
Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
|---|---|---|
|
Incidence of Parenteral Opioid Analgesic Use (Morphine Equivalents).
|
88.7 percentage of participants
|
91.3 percentage of participants
|
SECONDARY outcome
Timeframe: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.Population: Total of 210 patients evaluable for this assessment (106 Arm I \& 104 Arm II).
Mean days of parenteral opioid analgesic use.
Outcome measures
| Measure |
Arm I (Placebo)
n=106 Participants
Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
Arm II (Supersaturated Calcium Phosphate Rinse)
n=104 Participants
Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
|---|---|---|
|
Duration of Parenteral Opioid Analgesic Use (Morphine Equivalents).
|
14.2 Days
Standard Deviation 9.5
|
12.5 Days
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.Population: Total of 210 patients evaluable for this assessment (106 Arm I \& 104 Arm II).
Morphine equivalent dose in mg/kg/day
Outcome measures
| Measure |
Arm I (Placebo)
n=106 Participants
Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
Arm II (Supersaturated Calcium Phosphate Rinse)
n=104 Participants
Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
|---|---|---|
|
Total Dose of Parenteral Opioid Analgesic Used (Morphine Equivalents).
|
0.4 mg/kg/day of opioid analgesics
Interval 0.0 to 33.2
|
0.3 mg/kg/day of opioid analgesics
Interval 0.0 to 13.4
|
SECONDARY outcome
Timeframe: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.Population: Total of 210 patients evaluable for this assessment (106 Arm I \& 104 Arm II).
Total Parenteral Nutrition = yes
Outcome measures
| Measure |
Arm I (Placebo)
n=106 Participants
Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
Arm II (Supersaturated Calcium Phosphate Rinse)
n=104 Participants
Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
|---|---|---|
|
Incidence of Total Parenteral Nutrition (TPN) Administration.
|
78.3 percentage of participants
|
72.1 percentage of participants
|
SECONDARY outcome
Timeframe: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.Population: Total of 210 patients evaluable for this assessment (106 Arm I \& 104 Arm II).
Mean days of total parenteral nutrition (TPN) administration.
Outcome measures
| Measure |
Arm I (Placebo)
n=106 Participants
Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
Arm II (Supersaturated Calcium Phosphate Rinse)
n=104 Participants
Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
|---|---|---|
|
Duration of Total Parenteral Nutrition (TPN) Administration.
|
13.6 Number of days
Standard Deviation 9.9
|
11.4 Number of days
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.Population: Total of 210 patients evaluable for this assessment (106 Arm I \& 104 Arm II).
Fever and Neutropenia = yes
Outcome measures
| Measure |
Arm I (Placebo)
n=106 Participants
Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
Arm II (Supersaturated Calcium Phosphate Rinse)
n=104 Participants
Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
|---|---|---|
|
Incidence of Febrile Neutropenia
|
65.1 percentage of participants
|
67.3 percentage of participants
|
SECONDARY outcome
Timeframe: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.Population: Total of 210 patients evaluable for this assessment (106 Arm I \& 104 Arm II).
Invasive Bacterial Infection = yes
Outcome measures
| Measure |
Arm I (Placebo)
n=106 Participants
Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
Arm II (Supersaturated Calcium Phosphate Rinse)
n=104 Participants
Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
|---|---|---|
|
Incidence of Invasive Bacterial Infections
|
6.6 percentage of participants
|
7.7 percentage of participants
|
SECONDARY outcome
Timeframe: Day -1 (day prior to stem cell infusion) to Day 20 following transplantationPopulation: Evaluable patients defined as patients with ≥11 daily WHO assessments.
Area Under the Curve of Severity of Mucositis. According to mouth pain categorical rating scale ranges 0-10 with higher scores reflecting more severe pain.
Outcome measures
| Measure |
Arm I (Placebo)
n=91 Participants
Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
Arm II (Supersaturated Calcium Phosphate Rinse)
n=91 Participants
Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
|---|---|---|
|
Severity of Mucositis
|
45.5 units on a scale * day
Standard Deviation 36
|
44 units on a scale * day
Standard Deviation 35.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.Population: Analysis is not performed at this time due to no available funding and no human resource allocated to this study.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Placebo)
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Arm II (Supersaturated Calcium Phosphate Rinse)
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Placebo)
n=106 participants at risk
Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
Arm II (Supersaturated Calcium Phosphate Rinse)
n=104 participants at risk
Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
|---|---|---|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/106
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
0.96%
1/104
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/106
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
0.96%
1/104
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/106
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
0.96%
1/104
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
Other adverse events
| Measure |
Arm I (Placebo)
n=106 participants at risk
Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
Arm II (Supersaturated Calcium Phosphate Rinse)
n=104 participants at risk
Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
|---|---|---|
|
Immune system disorders
Allergic reaction
|
0.00%
0/106
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
0.96%
1/104
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/106
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
0.96%
1/104
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/106
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
0.96%
1/104
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
|
Nervous system disorders
Dysgeusia
|
1.9%
2/106
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
1.9%
2/104
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.94%
1/106
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
0.00%
0/104
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.94%
1/106
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
0.00%
0/104
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
11.3%
12/106
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
7.7%
8/104
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/106
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
0.96%
1/104
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
|
Gastrointestinal disorders
Oral pain
|
15.1%
16/106
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
12.5%
13/104
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
|
General disorders
Pain
|
0.94%
1/106
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
0.00%
0/104
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.94%
1/106
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
0.00%
0/104
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
|
Nervous system disorders
Seizure
|
0.94%
1/106
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
0.00%
0/104
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.94%
1/106
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
0.00%
0/104
Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
|
Additional Information
Results Reporting Coordinator
Children's Oncology Group
Phone: 626-447-0064
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER