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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA139118 | U.S. NIH Grant/Contract | View source |
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low accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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Women who have been treated for breast cancer may be at risk for lymphedema or arm swelling. Currently, there are no clear treatment guidelines for lymphedema. One treatment method used to treat lymphedema is the use of compression sleeves to encourage the flow of lymph fluid out of the arms and prevent arm swelling in the future. Another treatment method is more intensive and involves wearing compression sleeves as well as special compression bandages overnight. It is unclear whether the use of compression with both sleeves and bandaging is more effective in treating lymphedema than the use of compression sleeves alone. The purpose of this research study is to evaluate the effectiveness of the use of compression garments in preventing or slowing the progression of lymphedema in breast cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1A | No Intervention | Mild Lymphedema: Only required to meet with the lymphedema physical therapist | |
| Group 1B | Active Comparator | Mild Lymphedema: Fitted for compression sleeve |
|
| Group 2A | Active Comparator | Moderate lymphedema: Fitted with a compression sleeve |
|
| Group 2B | Active Comparator | Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compression Sleeve | Device | Worn for a minimum of 12 hours per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Identify the Number of Patients Who Experienced Reduction in Edema With Compression Garment Usage for Low Volume Lymphedema Associated With Breast Cancer Treatment | 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. | 5 years |
| 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 | 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. | 5 years |
| To Assess Survey Response Scores Regarding Symptoms Associated With Varying Degrees of Lymphedema | 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) | 5 years |
| To Assess Survey Response Scores Regarding Fear Avoidance Behavior Associated With Varying Degrees of Lymphedema |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alphonse G. Taghian, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1A | Mild Lymphedema: Only required to meet with the lymphedema physical therapist |
| FG001 | Group 1B | Mild Lymphedema: Fitted for compression sleeve Compression Sleeve: Worn for a minimum of 12 hours per day |
| FG002 | Group 2A | Moderate lymphedema: Fitted with a compression sleeve Compression Sleeve: Worn for a minimum of 12 hours per day |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1A | Mild Lymphedema: Only required to meet with the lymphedema physical therapist |
| BG001 | Group 1B | Mild Lymphedema: Fitted for compression sleeve Compression Sleeve: Worn for a minimum of 12 hours per day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | To Identify the Number of Patients Who Experienced Reduction in Edema With Compression Garment Usage for Low Volume Lymphedema Associated With Breast Cancer Treatment | 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. | 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 | Posted | Count of Participants | Participants | 5 years |
|
5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1A | Mild Lymphedema: Only required to meet with the lymphedema physical therapist |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arm lymphedema progressed beyond allowed study parameters | Blood and lymphatic system disorders | Systematic Assessment | 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 |
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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alphonse G Taghian, MD PhD | Massachusetts General Hospital | 617-726-6050 | 24369 | ataghian@partners.org |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Short-Stretch Compression Bandage | Device | Worn overnight at least 5 nights of the week |
|
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) |
| 5 years |
| To Assess Survey Response Scores Regarding Quality of Life as it Associated With Varying Degrees of Lymphedema | 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) | 5 years |
| To Assess Survey Response Scores Regarding Upper Extremity Function as it Associated With Varying Degrees of Lymphedema | 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) | 5 years |
| 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 | 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 | 5 years |
| BG002 | Group 2A | Moderate lymphedema: Fitted with a compression sleeve Compression Sleeve: Worn for a minimum of 12 hours per day |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Group 1A |
Mild Lymphedema: Only required to meet with the lymphedema physical therapist |
| OG001 | Group 1B | Mild Lymphedema: Fitted for compression sleeve Compression Sleeve: Worn for a minimum of 12 hours per day |
| OG002 | Group 2A | Moderate lymphedema: Fitted with a compression sleeve Compression Sleeve: Worn for a minimum of 12 hours per day |
| OG003 | 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 |
|
|
| Primary | 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 | 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. | 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 | Posted | Count of Participants | Participants | 5 years |
|
|
|
| Primary | To Assess Survey Response Scores Regarding Symptoms Associated With Varying Degrees of Lymphedema | 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) | 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. | Posted | Median | Full Range | units on a scale | 5 years |
|
|
|
| Primary | To Assess Survey Response Scores Regarding Fear Avoidance Behavior Associated With Varying Degrees of Lymphedema | 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) | 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. | Posted | Median | Full Range | units on a scale | 5 years |
|
|
|
| Primary | To Assess Survey Response Scores Regarding Quality of Life as it Associated With Varying Degrees of Lymphedema | 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) | 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. | Posted | Median | Full Range | units on a scale | 5 years |
|
|
|
| Primary | To Assess Survey Response Scores Regarding Upper Extremity Function as it Associated With Varying Degrees of Lymphedema | 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) | 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. | Posted | Median | Full Range | units on a scale | 5 years |
|
|
|
| Secondary | 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 | 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 | 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 | Posted | Count of Participants | Participants | 5 years |
|
|
|
| Secondary | 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 | 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 | Number and percentage of participants who had low-level arm swelling at their post-operative follow up are documented below | Posted | Count of Participants | Participants | 5 years |
|
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|
| 0 |
| 8 |
| 0 |
| 8 |
| 1 |
| 8 |
| EG001 | Group 1B | Mild Lymphedema: Fitted for compression sleeve Compression Sleeve: Worn for a minimum of 12 hours per day | 0 | 7 | 0 | 7 | 3 | 7 |
| EG002 | Group 2A | Moderate lymphedema: Fitted with a compression sleeve Compression Sleeve: Worn for a minimum of 12 hours per day | 0 | 4 | 0 | 4 | 2 | 4 |
| EG003 | 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 | 0 | 4 | 0 | 4 | 2 | 4 |
|
| Periodic mild pain while wearing compression garments | General disorders | Systematic Assessment | 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 |
|
| Presence of symptoms (e.g. swelling, tightness) in arm after completion of treatment period | General disorders | Systematic Assessment | 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. |
|
| Symptoms of leg edema prior to study enrollment date | Blood and lymphatic system disorders | Systematic Assessment | 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 |
|
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| D001941 |
| Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |