Trial Outcomes & Findings for Home-based Compression Therapy for Arm and Truncal Lymphedema in Breast Cancer (NCT NCT00880022)
NCT ID: NCT00880022
Last Updated: 2017-12-05
Results Overview
measured by tape and then volume was calculated.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
end of scheduled treatments-day 30 of treatment
Results posted on
2017-12-05
Participant Flow
Participant milestones
| Measure |
Arm Compression Only
Participants received a total of 30 treatments lasting up to approximately one hour per day for 30 days. Treatment One was provided under study staff supervision. Treatments Two through Thirty were self-administered, at home.
|
Arm, Trunk and Chest Compression
Participants received a total of 30 treatments lasting up to approximately one hour per day for 30 days. Treatment One was provided under study staff supervision. Treatments Two through Thirty were self-administered, at home.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
24
|
|
Overall Study
COMPLETED
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Home-based Compression Therapy for Arm and Truncal Lymphedema in Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm Compression Only
n=23 Participants
|
Arm, Trunck and Chest Compression
n=24 Participants
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
58.0 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
52.2 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
55.0 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
24 participants
n=7 Participants
|
47 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: end of scheduled treatments-day 30 of treatmentPopulation: Study withdrawals were not included.
measured by tape and then volume was calculated.
Outcome measures
| Measure |
Arm Compression Only
n=21 Participants
|
Arm, Trunck and Chest Compression
n=21 Participants
|
|---|---|---|
|
Arm Volume at End of Study
|
2376.52 ml
Interval 1934.68 to 2622.99
|
2539.93 ml
Interval 2168.28 to 3295.97
|
SECONDARY outcome
Timeframe: Before first treatment and end of all treatmentsPopulation: Number of participant symptoms
Lymphedema Symptom and Intensity Scale-Arm measures 30 symptoms yes no over the past 7 days . Total yes items added for number of symptoms.
Outcome measures
| Measure |
Arm Compression Only
n=21 Participants
|
Arm, Trunck and Chest Compression
n=21 Participants
|
|---|---|---|
|
Symptom Improvement
Baseline
|
12.0 Number of participant symptoms
Interval 7.5 to 16.0
|
15.0 Number of participant symptoms
Interval 9.5 to 20.0
|
|
Symptom Improvement
End of Treatment
|
6.0 Number of participant symptoms
Interval 4.0 to 11.5
|
10.0 Number of participant symptoms
Interval 6.0 to 17.5
|
Adverse Events
Arm Compression Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm, Trunck and Chest Compression
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place