Trial Outcomes & Findings for Early Detection and Intervention for Mild and Moderate Lymphedema in Patients Treated for Breast Cancer (NCT NCT00959985)
NCT ID: NCT00959985
Last Updated: 2017-05-30
Results Overview
Participants who are randomized to receive compression treatment will have their arm volume measured at regular intervals throughout the study period. Participants' arm volume, as measured by the validated Relative Volume Change (RVC) equation, at the end of the intervention period will be assessed to determine the efficacy of the compression garment intervention and whether or not it was successful in reducing the participants' arm edema to RVC\<10%.Data was collected in study participants enrolled in Group 1A and Group 1B only (15 patients total), and the percentage of participants who experienced reduction in edema is reported below.
TERMINATED
NA
23 participants
5 years
2017-05-30
Participant Flow
Participant milestones
| Measure |
Group 1A
Mild Lymphedema: Only required to meet with the lymphedema physical therapist
|
Group 1B
Mild Lymphedema: Fitted for compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day
|
Group 2A
Moderate lymphedema: Fitted with a compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day
|
Group 2B
Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage
Compression Sleeve: Worn for a minimum of 12 hours per day
Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
4
|
4
|
|
Overall Study
COMPLETED
|
8
|
7
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Early Detection and Intervention for Mild and Moderate Lymphedema in Patients Treated for Breast Cancer
Baseline characteristics by cohort
| Measure |
Group 1A
n=8 Participants
Mild Lymphedema: Only required to meet with the lymphedema physical therapist
|
Group 1B
n=7 Participants
Mild Lymphedema: Fitted for compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day
|
Group 2A
n=4 Participants
Moderate lymphedema: Fitted with a compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day
|
Group 2B
n=4 Participants
Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage
Compression Sleeve: Worn for a minimum of 12 hours per day
Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week
|
Total
n=23 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: This outcome measure was compared between Group 1A (control) and Group 1B (compression garment). No data was collected for this outcome in Groups 2A and 2B
Participants who are randomized to receive compression treatment will have their arm volume measured at regular intervals throughout the study period. Participants' arm volume, as measured by the validated Relative Volume Change (RVC) equation, at the end of the intervention period will be assessed to determine the efficacy of the compression garment intervention and whether or not it was successful in reducing the participants' arm edema to RVC\<10%.Data was collected in study participants enrolled in Group 1A and Group 1B only (15 patients total), and the percentage of participants who experienced reduction in edema is reported below.
Outcome measures
| Measure |
Group 1A
n=8 Participants
Mild Lymphedema: Only required to meet with the lymphedema physical therapist
|
Group 1B
n=7 Participants
Mild Lymphedema: Fitted for compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day
|
Group 2A
Moderate lymphedema: Fitted with a compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day
|
Group 2B
Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage
Compression Sleeve: Worn for a minimum of 12 hours per day
Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week
|
|---|---|---|---|---|
|
To Identify the Number of Patients Who Experienced Reduction in Edema With Compression Garment Usage for Low Volume Lymphedema Associated With Breast Cancer Treatment
|
7 Participants
|
4 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: This outcome measure was compared between Groups 2A and 2B. No data was collected for Group 1A and 1B as this outcome does not apply to these groups
Participants who are randomized to receive compression treatment with/without night bandaging will have their arm volume measured at regular intervals throughout the study period. Participants' arm volume, as measured by the validated Relative Volume Change (RVC) equation, at the end of the intervention period will be assessed to determine the efficacy of the compression garment intervention and whether or not it was successful in reducing the participants' arm edema to RVC\<10%. Data was collected in participants enrolled in Group 2A and 2B only (8 participants total), and the percentage of participants who experienced reduction in edema is reported below.
Outcome measures
| Measure |
Group 1A
Mild Lymphedema: Only required to meet with the lymphedema physical therapist
|
Group 1B
Mild Lymphedema: Fitted for compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day
|
Group 2A
n=4 Participants
Moderate lymphedema: Fitted with a compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day
|
Group 2B
n=4 Participants
Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage
Compression Sleeve: Worn for a minimum of 12 hours per day
Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week
|
|---|---|---|---|---|
|
To Identify the Number of Patients Who Experienced Reduction in Edema With Compression Garments +/- Night Compression Bandaging for Moderate Volume Lymphedema Due to Breast Cancer Treatment
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Median scores of the symptom-related questions on the LEFT-BC survey, per group, are indicated below. Participants who did not complete or return surveys due to non-compliance were excluded from this analysis.
Symptoms were assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. The responses were scored on a scale from 0-51, where higher score was associated with presence of more symptoms (0=no symptoms, 51 = most symptoms)
Outcome measures
| Measure |
Group 1A
n=5 Participants
Mild Lymphedema: Only required to meet with the lymphedema physical therapist
|
Group 1B
n=7 Participants
Mild Lymphedema: Fitted for compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day
|
Group 2A
n=2 Participants
Moderate lymphedema: Fitted with a compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day
|
Group 2B
n=1 Participants
Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage
Compression Sleeve: Worn for a minimum of 12 hours per day
Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week
|
|---|---|---|---|---|
|
To Assess Survey Response Scores Regarding Symptoms Associated With Varying Degrees of Lymphedema
|
4 units on a scale
Interval 3.25 to 10.0
|
6.46 units on a scale
Interval 1.0 to 20.0
|
6.58 units on a scale
Interval 5.5 to 7.67
|
2.4 units on a scale
Interval 2.4 to 2.4
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Median scores for the fear avoidance behavior section on the LEFT-BC survey, per group, are indicated below. Participants who did not complete or return surveys due to non-compliance were excluded from this analysis.
Fear avoidance behavior was assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. Participant responses were scored on a scale from 7-28, where higher score was associated with higher level of fear of using arm (7= least fear level; 28= most fear level)
Outcome measures
| Measure |
Group 1A
n=5 Participants
Mild Lymphedema: Only required to meet with the lymphedema physical therapist
|
Group 1B
n=7 Participants
Mild Lymphedema: Fitted for compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day
|
Group 2A
n=2 Participants
Moderate lymphedema: Fitted with a compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day
|
Group 2B
n=1 Participants
Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage
Compression Sleeve: Worn for a minimum of 12 hours per day
Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week
|
|---|---|---|---|---|
|
To Assess Survey Response Scores Regarding Fear Avoidance Behavior Associated With Varying Degrees of Lymphedema
|
13.3 units on a scale
Interval 10.0 to 20.25
|
16.5 units on a scale
Interval 12.67 to 19.4
|
20.75 units on a scale
Interval 19.67 to 21.8
|
17 units on a scale
Interval 17.0 to 17.0
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Median scores for the quality of life questions on the LEFT-BC survey, per group, are indicated below. Participants who did not complete or return surveys due to non-compliance were excluded from this analysis.
Quality of life was assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. Participant responses were scored on a scale from 0-141, where higher score was associated with higher post-operative quality of life (0= worst; 141= best)
Outcome measures
| Measure |
Group 1A
n=5 Participants
Mild Lymphedema: Only required to meet with the lymphedema physical therapist
|
Group 1B
n=7 Participants
Mild Lymphedema: Fitted for compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day
|
Group 2A
n=2 Participants
Moderate lymphedema: Fitted with a compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day
|
Group 2B
n=1 Participants
Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage
Compression Sleeve: Worn for a minimum of 12 hours per day
Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week
|
|---|---|---|---|---|
|
To Assess Survey Response Scores Regarding Quality of Life as it Associated With Varying Degrees of Lymphedema
|
102.5 units on a scale
Interval 89.25 to 124.8
|
110 units on a scale
Interval 98.1 to 128.0
|
99.17 units on a scale
Interval 90.5 to 107.8
|
106.8 units on a scale
Interval 106.8 to 106.8
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Median scores for the upper extremity function questions on the LEFT-BC survey, per group, are indicated below. Participants who did not complete or return surveys due to non-compliance were excluded from this analysis.
Upper extremity functions were assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. Participant responses were scored on a scale from 19-95, where higher score was associated with more difficulty utilizing arm for daily activities (19 = least difficulty; 95 = most difficulty)
Outcome measures
| Measure |
Group 1A
n=5 Participants
Mild Lymphedema: Only required to meet with the lymphedema physical therapist
|
Group 1B
n=7 Participants
Mild Lymphedema: Fitted for compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day
|
Group 2A
n=2 Participants
Moderate lymphedema: Fitted with a compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day
|
Group 2B
n=1 Participants
Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage
Compression Sleeve: Worn for a minimum of 12 hours per day
Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week
|
|---|---|---|---|---|
|
To Assess Survey Response Scores Regarding Upper Extremity Function as it Associated With Varying Degrees of Lymphedema
|
21.2 units on a scale
Interval 14.25 to 49.25
|
24.5 units on a scale
Interval 19.0 to 43.5
|
24.8 units on a scale
Interval 22.8 to 26.8
|
19.6 units on a scale
Interval 19.6 to 19.6
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: The number and percentage of participants in each group who had at least 2 known risk factors for lymphedema is documented in the outcome measure data table below
Surgical and radiation therapy risk factors for lymphedema (surgery to lymph nodes, radiation to lymph nodes), as well as risk factors unrelated to breast cancer treatment such as high BMI were collected upon medical record review
Outcome measures
| Measure |
Group 1A
n=8 Participants
Mild Lymphedema: Only required to meet with the lymphedema physical therapist
|
Group 1B
n=7 Participants
Mild Lymphedema: Fitted for compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day
|
Group 2A
n=4 Participants
Moderate lymphedema: Fitted with a compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day
|
Group 2B
n=4 Participants
Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage
Compression Sleeve: Worn for a minimum of 12 hours per day
Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week
|
|---|---|---|---|---|
|
To Identify the Number of Patients With Risk Factors Associated With the Onset of Lymphedema That Are Both Related and Unrelated to Treatment for Breast Cancer
|
4 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Number and percentage of participants who had low-level arm swelling at their post-operative follow up are documented below
We recorded the number of participants who had low-level arm swelling, as defined by the Relative Volume Change (RVC) equation of \>5%-\<10%, at the time of their post-operative follow up to determine if women who had low-level arm swelling were more likely to develop lymphedema
Outcome measures
| Measure |
Group 1A
n=8 Participants
Mild Lymphedema: Only required to meet with the lymphedema physical therapist
|
Group 1B
n=7 Participants
Mild Lymphedema: Fitted for compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day
|
Group 2A
n=4 Participants
Moderate lymphedema: Fitted with a compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day
|
Group 2B
n=4 Participants
Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage
Compression Sleeve: Worn for a minimum of 12 hours per day
Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week
|
|---|---|---|---|---|
|
To Evaluate the Number of Patients With Low-level Arm Swelling in Order to Understand the Natural History of Lymphedema After Treatment for Breast Cancer
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
Adverse Events
Group 1A
Group 1B
Group 2A
Group 2B
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1A
n=8 participants at risk
Mild Lymphedema: Only required to meet with the lymphedema physical therapist
|
Group 1B
n=7 participants at risk
Mild Lymphedema: Fitted for compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day
|
Group 2A
n=4 participants at risk
Moderate lymphedema: Fitted with a compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day
|
Group 2B
n=4 participants at risk
Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage
Compression Sleeve: Worn for a minimum of 12 hours per day
Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Arm lymphedema progressed beyond allowed study parameters
|
0.00%
0/8 • 5 years
|
42.9%
3/7 • Number of events 3 • 5 years
|
25.0%
1/4 • Number of events 1 • 5 years
|
25.0%
1/4 • Number of events 1 • 5 years
|
|
General disorders
Periodic mild pain while wearing compression garments
|
0.00%
0/8 • 5 years
|
0.00%
0/7 • 5 years
|
25.0%
1/4 • Number of events 1 • 5 years
|
0.00%
0/4 • 5 years
|
|
General disorders
Presence of symptoms (e.g. swelling, tightness) in arm after completion of treatment period
|
12.5%
1/8 • Number of events 1 • 5 years
|
0.00%
0/7 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/4 • 5 years
|
|
Blood and lymphatic system disorders
Symptoms of leg edema prior to study enrollment date
|
0.00%
0/8 • 5 years
|
0.00%
0/7 • 5 years
|
0.00%
0/4 • 5 years
|
25.0%
1/4 • Number of events 1 • 5 years
|
Additional Information
Dr. Alphonse G Taghian, MD PhD
Massachusetts General Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place