Trial Outcomes & Findings for Propranolol Dose Escalation in Lymphedema in Patients (NCT NCT02595996)
NCT ID: NCT02595996
Last Updated: 2021-10-22
Results Overview
To assess whether patients tolerated propranolol
TERMINATED
PHASE2
1 participants
8 weeks
2021-10-22
Participant Flow
Participant milestones
| Measure |
Treatment
Patients will be given propranolol in escalating doses
Propranolol: escalating doses of propranolol from 1mg/kg/day to 2mg/kg/day to 3mg/kg/day
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Propranolol Dose Escalation in Lymphedema in Patients
Baseline characteristics by cohort
| Measure |
Treatment
n=1 Participants
Patients will be given propranolol in escalating doses
Propranolol: escalating doses of propranolol from 1mg/kg/day to 2mg/kg/day to 3mg/kg/day
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Study terminated due to lack of funding. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).
To assess whether patients tolerated propranolol
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 weeksPopulation: Study terminated due to lack of funding. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).
To assess subjective lymphedema symptoms improvements only - whether patients' general quality of life symptoms improved on propranolol treatment by self-reported questionnaires (SF 36)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 weeksPopulation: Study terminated due to lack of funding. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).
To assess whether patients' lymphedema signs are improved on propranolol by weight (BMI kg/m\^2) - objective signs of improvement of their lymphedema
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 weeksPopulation: Study terminated due to lack of funding. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).
To assess whether patients' lymphedema signs are improved on propranolol by limb girth discrepancy measurement (%) - objective signs of improvement of their lymphedema
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 8 weeksPopulation: Study terminated due to lack of funding. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).
To assess whether patients' lymphedema signs are improved on propranolol - the decrease in fluid retention will be calculated by the measurement of fat (a number) divide by the measurement of fluid (a number) to yield a ratio - if a patient has a lower ratio at 8 weeks than at baseline, they will be reported in this category.
Outcome measures
Outcome data not reported
Adverse Events
Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
June K. Wu, MD
Columbia University Irving Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place