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

NCT ID: NCT00959985

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2014-08-31

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.

Conditions

Lymphedema; Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1A

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group 1B

Mild Lymphedema: Fitted for compression sleeve

Group Type: ACTIVE_COMPARATOR

Compression Sleeve

Intervention Type: DEVICE

Worn for a minimum of 12 hours per day

Group 2A

Moderate lymphedema: Fitted with a compression sleeve

Group Type: ACTIVE_COMPARATOR

Compression Sleeve

Intervention Type: DEVICE

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

Group Type: ACTIVE_COMPARATOR

Compression Sleeve

Intervention Type: DEVICE

Worn for a minimum of 12 hours per day

Short-Stretch Compression Bandage

Intervention Type: DEVICE

Worn overnight at least 5 nights of the week

Interventions

Compression Sleeve

Worn for a minimum of 12 hours per day

Intervention Type: DEVICE

Short-Stretch Compression Bandage

Worn overnight at least 5 nights of the week

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Alphonse Taghian, MD, PhD

Chief of Breast Service, Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alphonse G. Taghian, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

R01CA139118

Identifier Type: NIH

Identifier Source: secondary_id

View Link

08-308

Identifier Type: -

Identifier Source: org_study_id