Back to results

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

Primary Purpose

Lymphedema, Breast Cancer

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Compression Sleeve

Short-Stretch Compression Bandage

About this trial

This is an interventional treatment trial for Lymphedema focused on measuring compression sleeve, compression bandage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Participants must have histologically or cytologically confirmed invasive or in-situ carcinoma of the breast
Participants must have undergone sentinel lymph node mapping or axillary dissection
Participants must have had a pre-operative Perometer measurement, and consecutive measurement at 4-6 month intervals prior to the onset of low volume edema (>5% from baseline)
Age > 18 years
Life expectancy of greater than 1 year
Participants must have a Perometer measurement of 5% or greater volume difference (RVC) to qualify for randomization
Ability to understand and willingness to sign a written informed consent document
Willingness to comply with required follow up Perometer measurements and clinical visits

Exclusion Criteria:

Known metastatic disease or other locally advanced disease in the thoracic or cervical regions
Any patient who will not be returning routinely for follow-up
Known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
History of primary lymphedema
History of prior surgery or radiation to the head, neck, upper limb, or trunk
Evidence that axillary lymph node malignancy is causing lymphedema due to recurrence as per physician discretion
Any patient who has bilateral lymph node mapping or dissection
Any patient with a current case of cellulitis
Patients with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancer are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Arm Label

Group 1A

Group 1B

Group 2A

Group 2B

Arm Description

Mild Lymphedema: Only required to meet with the lymphedema physical therapist

Mild Lymphedema: Fitted for compression sleeve

Moderate lymphedema: Fitted with a compression sleeve

Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage

Outcomes

Primary Outcome Measures

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.

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.

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)

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)

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)

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)

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT00959985

First Posted

August 14, 2009

Last Updated

April 26, 2017

Sponsor

Massachusetts General Hospital

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00959985

Brief Title

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

Official Title

Early Detection and Intervention for Mild and Moderate Lymphedema in Patients Treated for Breast Cancer: A Randomized Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Terminated

Why Stopped

low accrual

Study Start Date

August 2009 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

Because no one knows which of the study options is best, participant's will be randomized into one of the study groups. Participants with mild lymphedema will be randomized into either Group 1A or Group 1B. Participants with moderate lymphedema will be randomized into either Group 2A or Group 2B. All study participants will meet with a lymphedema physical therapist to review daily shoulder range of motion exercises to help minimize their arm swelling. They will be asked to record their range of motion exercises and activities in a study treatment journal. Participants will bring their journal to each study visit (every 4 weeks). Group 1A will only be required to meet with the lymphedema physical therapist as described above. Group 1B and Group 2A will be fitted with a compression sleeve at their first lymphedema physical therapy visit. They will wear the sleeve for a minimum of 12 hours per day. Group 2B will also be fitted with a compression sleeve at their first lymphedema physical therapy visit and will wear the sleeve for a minimum of 12 hours per day. They will also be instructed to wear a short-stretch compression bandage that goes from the top of the hand to the armpit. They will be asked to wear this compression bandage during the night. The overnight compression bandage should be worn for at least 5 nights out of the week. Participants will come to the clinic every 4 weeks. The following tests and procedures will be performed: height and weight measurements; review of any side effects; arm volume measurements for both arms; questionnaire.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphedema, Breast Cancer

Keywords

compression sleeve, compression bandage

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1A

Arm Type

No Intervention

Arm Description

Mild Lymphedema: Only required to meet with the lymphedema physical therapist

Arm Title

Group 1B

Arm Type

Active Comparator

Arm Description

Mild Lymphedema: Fitted for compression sleeve

Arm Title

Group 2A

Arm Type

Active Comparator

Arm Description

Moderate lymphedema: Fitted with a compression sleeve

Arm Title

Group 2B

Arm Type

Active Comparator

Arm Description

Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage

Intervention Type

Device

Intervention Name(s)

Compression Sleeve

Intervention Description

Worn for a minimum of 12 hours per day

Intervention Type

Device

Intervention Name(s)

Short-Stretch Compression Bandage

Intervention Description

Worn overnight at least 5 nights of the week

Primary Outcome Measure Information:

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

Description

Time Frame

5 years

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

Description

Time Frame

5 years

Title

To Assess Survey Response Scores Regarding Symptoms Associated With Varying Degrees of Lymphedema

Description

Time Frame

5 years

Title

To Assess Survey Response Scores Regarding Fear Avoidance Behavior Associated With Varying Degrees of Lymphedema

Description

Time Frame

5 years

Title

To Assess Survey Response Scores Regarding Quality of Life as it Associated With Varying Degrees of Lymphedema

Description

Time Frame

5 years

Title

To Assess Survey Response Scores Regarding Upper Extremity Function as it Associated With Varying Degrees of Lymphedema

Description

Time Frame

5 years

Secondary Outcome Measure Information:

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

Description

Time Frame

5 years

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

Description

Time Frame

5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants must have histologically or cytologically confirmed invasive or in-situ carcinoma of the breast Participants must have undergone sentinel lymph node mapping or axillary dissection Participants must have had a pre-operative Perometer measurement, and consecutive measurement at 4-6 month intervals prior to the onset of low volume edema (>5% from baseline) Age > 18 years Life expectancy of greater than 1 year Participants must have a Perometer measurement of 5% or greater volume difference (RVC) to qualify for randomization Ability to understand and willingness to sign a written informed consent document Willingness to comply with required follow up Perometer measurements and clinical visits Exclusion Criteria: Known metastatic disease or other locally advanced disease in the thoracic or cervical regions Any patient who will not be returning routinely for follow-up Known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events History of primary lymphedema History of prior surgery or radiation to the head, neck, upper limb, or trunk Evidence that axillary lymph node malignancy is causing lymphedema due to recurrence as per physician discretion Any patient who has bilateral lymph node mapping or dissection Any patient with a current case of cellulitis Patients with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancer are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alphonse G. Taghian, MD, PhD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs