We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Early Detection and Intervention for Mild and Moderate Lymphedema in Patients Treated for Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00959985
Recruitment Status : Terminated (low accrual)
First Posted : August 17, 2009
Results First Posted : April 27, 2017
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alphonse Taghian, MD, PhD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lymphedema
Breast Cancer
Interventions Device: Compression Sleeve
Device: Short-Stretch Compression Bandage
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1A Group 1B Group 2A Group 2B
Hide Arm/Group Description Mild Lymphedema: Only required to meet with the lymphedema physical therapist

Mild Lymphedema: Fitted for compression sleeve

Compression Sleeve: Worn for a minimum of 12 hours per day

Moderate lymphedema: Fitted with a compression sleeve

Compression Sleeve: Worn for a minimum of 12 hours per day

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

Period Title: Overall Study
Started 8 7 4 4
Completed 8 7 4 4
Not Completed 0 0 0 0
Arm/Group Title Group 1A Group 1B Group 2A Group 2B Total
Hide Arm/Group Description Mild Lymphedema: Only required to meet with the lymphedema physical therapist

Mild Lymphedema: Fitted for compression sleeve

Compression Sleeve: Worn for a minimum of 12 hours per day

Moderate lymphedema: Fitted with a compression sleeve

Compression Sleeve: Worn for a minimum of 12 hours per day

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 of all reporting groups
Overall Number of Baseline Participants 8 7 4 4 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 4 participants 4 participants 23 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  62.5%
5
  71.4%
4
 100.0%
3
  75.0%
17
  73.9%
>=65 years
3
  37.5%
2
  28.6%
0
   0.0%
1
  25.0%
6
  26.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 4 participants 4 participants 23 participants
Female
8
 100.0%
7
 100.0%
4
 100.0%
4
 100.0%
23
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title To Identify the Number of Patients Who Experienced Reduction in Edema With Compression Garment Usage for Low Volume Lymphedema Associated With Breast Cancer Treatment
Hide Description 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.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Group 1A Group 1B Group 2A Group 2B
Hide Arm/Group Description:
Mild Lymphedema: Only required to meet with the lymphedema physical therapist

Mild Lymphedema: Fitted for compression sleeve

Compression Sleeve: Worn for a minimum of 12 hours per day

Moderate lymphedema: Fitted with a compression sleeve

Compression Sleeve: Worn for a minimum of 12 hours per day

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 Number of Participants Analyzed 8 7 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
7
  87.5%
4
  57.1%
2.Primary Outcome
Title 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
Hide Description 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.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Group 1A Group 1B Group 2A Group 2B
Hide Arm/Group Description:
Mild Lymphedema: Only required to meet with the lymphedema physical therapist

Mild Lymphedema: Fitted for compression sleeve

Compression Sleeve: Worn for a minimum of 12 hours per day

Moderate lymphedema: Fitted with a compression sleeve

Compression Sleeve: Worn for a minimum of 12 hours per day

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 Number of Participants Analyzed 0 0 4 4
Measure Type: Count of Participants
Unit of Measure: Participants
0 0
2
  50.0%
3
  75.0%
3.Primary Outcome
Title To Assess Survey Response Scores Regarding Symptoms Associated With Varying Degrees of Lymphedema
Hide Description 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)
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1A Group 1B Group 2A Group 2B
Hide Arm/Group Description:
Mild Lymphedema: Only required to meet with the lymphedema physical therapist

Mild Lymphedema: Fitted for compression sleeve

Compression Sleeve: Worn for a minimum of 12 hours per day

Moderate lymphedema: Fitted with a compression sleeve

Compression Sleeve: Worn for a minimum of 12 hours per day

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 Number of Participants Analyzed 5 7 2 1
Median (Full Range)
Unit of Measure: units on a scale
4
(3.25 to 10)
6.46
(1 to 20)
6.58
(5.5 to 7.67)
2.4
(2.4 to 2.4)
4.Primary Outcome
Title To Assess Survey Response Scores Regarding Fear Avoidance Behavior Associated With Varying Degrees of Lymphedema
Hide Description 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)
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1A Group 1B Group 2A Group 2B
Hide Arm/Group Description:
Mild Lymphedema: Only required to meet with the lymphedema physical therapist

Mild Lymphedema: Fitted for compression sleeve

Compression Sleeve: Worn for a minimum of 12 hours per day

Moderate lymphedema: Fitted with a compression sleeve

Compression Sleeve: Worn for a minimum of 12 hours per day

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 Number of Participants Analyzed 5 7 2 1
Median (Full Range)
Unit of Measure: units on a scale
13.3
(10 to 20.25)
16.5
(12.67 to 19.4)
20.75
(19.67 to 21.8)
17
(17 to 17)
5.Primary Outcome
Title To Assess Survey Response Scores Regarding Quality of Life as it Associated With Varying Degrees of Lymphedema
Hide Description 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)
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1A Group 1B Group 2A Group 2B
Hide Arm/Group Description:
Mild Lymphedema: Only required to meet with the lymphedema physical therapist

Mild Lymphedema: Fitted for compression sleeve

Compression Sleeve: Worn for a minimum of 12 hours per day

Moderate lymphedema: Fitted with a compression sleeve

Compression Sleeve: Worn for a minimum of 12 hours per day

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 Number of Participants Analyzed 5 7 2 1
Median (Full Range)
Unit of Measure: units on a scale
102.5
(89.25 to 124.8)
110
(98.1 to 128)
99.17
(90.5 to 107.8)
106.8
(106.8 to 106.8)
6.Primary Outcome
Title To Assess Survey Response Scores Regarding Upper Extremity Function as it Associated With Varying Degrees of Lymphedema
Hide Description 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)
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1A Group 1B Group 2A Group 2B
Hide Arm/Group Description:
Mild Lymphedema: Only required to meet with the lymphedema physical therapist

Mild Lymphedema: Fitted for compression sleeve

Compression Sleeve: Worn for a minimum of 12 hours per day

Moderate lymphedema: Fitted with a compression sleeve

Compression Sleeve: Worn for a minimum of 12 hours per day

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 Number of Participants Analyzed 5 7 2 1
Median (Full Range)
Unit of Measure: units on a scale
21.2
(14.25 to 49.25)
24.5
(19 to 43.5)
24.8
(22.8 to 26.8)
19.6
(19.6 to 19.6)
7.Secondary Outcome
Title 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
Hide Description 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
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Group 1A Group 1B Group 2A Group 2B
Hide Arm/Group Description:
Mild Lymphedema: Only required to meet with the lymphedema physical therapist

Mild Lymphedema: Fitted for compression sleeve

Compression Sleeve: Worn for a minimum of 12 hours per day

Moderate lymphedema: Fitted with a compression sleeve

Compression Sleeve: Worn for a minimum of 12 hours per day

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 Number of Participants Analyzed 8 7 4 4
Measure Type: Count of Participants
Unit of Measure: Participants
4
  50.0%
6
  85.7%
2
  50.0%
4
 100.0%
8.Secondary Outcome
Title 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
Hide Description 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
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Number and percentage of participants who had low-level arm swelling at their post-operative follow up are documented below
Arm/Group Title Group 1A Group 1B Group 2A Group 2B
Hide Arm/Group Description:
Mild Lymphedema: Only required to meet with the lymphedema physical therapist

Mild Lymphedema: Fitted for compression sleeve

Compression Sleeve: Worn for a minimum of 12 hours per day

Moderate lymphedema: Fitted with a compression sleeve

Compression Sleeve: Worn for a minimum of 12 hours per day

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 Number of Participants Analyzed 8 7 4 4
Measure Type: Count of Participants
Unit of Measure: Participants
3
  37.5%
2
  28.6%
2
  50.0%
2
  50.0%
Time Frame 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1A Group 1B Group 2A Group 2B
Hide Arm/Group Description Mild Lymphedema: Only required to meet with the lymphedema physical therapist

Mild Lymphedema: Fitted for compression sleeve

Compression Sleeve: Worn for a minimum of 12 hours per day

Moderate lymphedema: Fitted with a compression sleeve

Compression Sleeve: Worn for a minimum of 12 hours per day

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

All-Cause Mortality
Group 1A Group 1B Group 2A Group 2B
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)      0/7 (0.00%)      0/4 (0.00%)      0/4 (0.00%)    
Hide Serious Adverse Events
Group 1A Group 1B Group 2A Group 2B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/7 (0.00%)      0/4 (0.00%)      0/4 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1A Group 1B Group 2A Group 2B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/8 (12.50%)      3/7 (42.86%)      2/4 (50.00%)      2/4 (50.00%)    
Blood and lymphatic system disorders         
Arm lymphedema progressed beyond allowed study parameters  [1]  0/8 (0.00%)  0 3/7 (42.86%)  3 1/4 (25.00%)  1 1/4 (25.00%)  1
Symptoms of leg edema prior to study enrollment date  [2]  0/8 (0.00%)  0 0/7 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1
General disorders         
Periodic mild pain while wearing compression garments  [3]  0/8 (0.00%)  0 0/7 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0
Presence of symptoms (e.g. swelling, tightness) in arm after completion of treatment period  [4]  1/8 (12.50%)  1 0/7 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Participants who experienced an increase in arm volume >10% and did not wish to be re-randomized were removed from study and treated at discretion of physical therapist. They remained on active lymphedema screening at treating institution
[2]
One participant experienced increased leg swelling and then underwent a lower-extremity venous ultrasound to rule out blood clot.This was negative and the protocol treatment she received for breast cancer-related lymphedema was not interrupted
[3]
One participant experienced periodic mild pain while wearing compression garments. The physical therapist advised the participant to not wear the garments when they were causing her pain; participant continued study without further complication
[4]
After completing study requirements 1 participant contacted the physical therapist (PT) to report feeling more symptoms in the arm. The PT determined her symptoms were related to her cording, not lymphedema, and recommended stretching exercises.
This trial was terminated due to slow accrual and small number of subjects for whom data was collected (23 out of expected 334). Study did not reach statistical power to conduct detailed analysis, results should be interpreted with this in mind
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Alphonse G Taghian, MD PhD
Organization: Massachusetts General Hospital
Phone: 617-726-6050 ext 24369
EMail: ataghian@partners.org
Layout table for additonal information
Responsible Party: Alphonse Taghian, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00959985    
Other Study ID Numbers: 08-308
R01CA139118 ( U.S. NIH Grant/Contract )
First Submitted: August 14, 2009
First Posted: August 17, 2009
Results First Submitted: January 4, 2017
Results First Posted: April 27, 2017
Last Update Posted: May 30, 2017