Trial Outcomes & Findings for Feasibility - Beta Adrenergic Blockade (BB) in Cervical Cancer (CX) (NCT NCT01902966)
NCT ID: NCT01902966
Last Updated: 2021-10-12
Results Overview
To determine the proportion of patients completing symptom inventory, anxiety and depression survey, pain inventory, and quality of life surveys (MDASI, HADS\< BPI, FACT-Cx).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
2 months
Results posted on
2021-10-12
Participant Flow
Recruitment period: 09/2013 until 02/2015. All the recruitment was done in a medical clinic setting.
6 patients were registered on this study but only 5 received treatment - 1 patient signed consent but did not receive any treatment on study due to physician decision after consultation with cardiology
Participant milestones
| Measure |
Propranolol + Relaxation/Guided Imagery
A starting dose of propranolol 20 mg is taken by mouth twice a day (40 mg/day). If patient tolerates the initial dose (no hypotension or bradycardia), dose increased to 40 mg by mouth twice a day at start of second month of therapy. Patients record study medication taken each day in a pill diary. Patient given an MP3 player with an audio recording to listen to 2 times a week for up to 4 months. The recording lasts 20 minutes. Relaxation diary completed stating whether patient was able to complete the sessions and whether they had any difficulties with it.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Propranolol + Relaxation/Guided Imagery
A starting dose of propranolol 20 mg is taken by mouth twice a day (40 mg/day). If patient tolerates the initial dose (no hypotension or bradycardia), dose increased to 40 mg by mouth twice a day at start of second month of therapy. Patients record study medication taken each day in a pill diary. Patient given an MP3 player with an audio recording to listen to 2 times a week for up to 4 months. The recording lasts 20 minutes. Relaxation diary completed stating whether patient was able to complete the sessions and whether they had any difficulties with it.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Feasibility - Beta Adrenergic Blockade (BB) in Cervical Cancer (CX)
Baseline characteristics by cohort
| Measure |
Propranolol + Relaxation/Guided Imagery
n=6 Participants
A starting dose of propranolol 20 mg is taken by mouth twice a day (40 mg/day). If patient tolerates the initial dose (no hypotension or bradycardia), dose increased to 40 mg by mouth twice a day at start of second month of therapy. Patients record study medication taken each day in a pill diary. Patient given an MP3 player with an audio recording to listen to 2 times a week for up to 4 months. The recording lasts 20 minutes. Relaxation diary completed stating whether patient was able to complete the sessions and whether they had any difficulties with it.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age, Continuous
|
50 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: data were not collected due to protocol terminated early.
To determine the proportion of patients completing symptom inventory, anxiety and depression survey, pain inventory, and quality of life surveys (MDASI, HADS\< BPI, FACT-Cx).
Outcome measures
Outcome data not reported
Adverse Events
Propranolol + Relaxation/Guided Imagery
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Propranolol + Relaxation/Guided Imagery
n=5 participants at risk
A starting dose of propranolol 20 mg is taken by mouth twice a day (40 mg/day). If patient tolerates the initial dose (no hypotension or bradycardia), dose increased to 40 mg by mouth twice a day at start of second month of therapy. Patients record study medication taken each day in a pill diary. Patient given an MP3 player with an audio recording to listen to 2 times a week for up to 4 months. The recording lasts 20 minutes. Relaxation diary completed stating whether patient was able to complete the sessions and whether they had any difficulties with it.
|
|---|---|
|
Investigations
Urine Output decreased
|
20.0%
1/5 • baseline, 2 months and 4 months
|
Other adverse events
| Measure |
Propranolol + Relaxation/Guided Imagery
n=5 participants at risk
A starting dose of propranolol 20 mg is taken by mouth twice a day (40 mg/day). If patient tolerates the initial dose (no hypotension or bradycardia), dose increased to 40 mg by mouth twice a day at start of second month of therapy. Patients record study medication taken each day in a pill diary. Patient given an MP3 player with an audio recording to listen to 2 times a week for up to 4 months. The recording lasts 20 minutes. Relaxation diary completed stating whether patient was able to complete the sessions and whether they had any difficulties with it.
|
|---|---|
|
Vascular disorders
Hypotension
|
40.0%
2/5 • baseline, 2 months and 4 months
|
|
General disorders
Edema limbs
|
20.0%
1/5 • baseline, 2 months and 4 months
|
|
General disorders
Fatigue
|
20.0%
1/5 • baseline, 2 months and 4 months
|
|
General disorders
Pain
|
40.0%
2/5 • baseline, 2 months and 4 months
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • baseline, 2 months and 4 months
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • baseline, 2 months and 4 months
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • baseline, 2 months and 4 months
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • baseline, 2 months and 4 months
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • baseline, 2 months and 4 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
20.0%
1/5 • baseline, 2 months and 4 months
|
|
Investigations
Creatinine increased
|
20.0%
1/5 • baseline, 2 months and 4 months
|
|
Investigations
BUN increased
|
20.0%
1/5 • baseline, 2 months and 4 months
|
Additional Information
Lois M. Ramondetta, MD, Professor, Gynecologic Oncology & Reproductive Medicine
UT MD Anderson Cancer Center
Phone: 713-745-0307
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place