Early Detection and Intervention for Mild and Moderate Lymphedema in Patients Treated for Breast Cancer - Full Text View

Sponsor:	Massachusetts General Hospital
Collaborator:	National Cancer Institute (NCI)
Information provided by (Responsible Party):	Alphonse Taghian, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00959985

Purpose

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.

Condition	Intervention	Phase
Lymphedema Breast Cancer	Device: Compression Sleeve Device: Short-Stretch Compression Bandage	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Early Detection and Intervention for Mild and Moderate Lymphedema in Patients Treated for Breast Cancer: A Randomized Trial

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Lymphedema

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

To assess the efficacy of early intervention using compression garments for low volume lymphedema associated with breast cancer treatment. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
To assess the efficacy of compression garments +/- night compression bandaging for moderate volume lymphedema due to breast cancer treatment, as a method for the alleviation of lymphedema. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
To assess symptom clusters, treatment adherence, fear avoidance behavior, quality of life, and upper extremity function as it is associated with varying degrees of lymphedema. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To identify risk factors associated with the onset of lymphedema that are both related and unrelated to treatment for breast cancer [ Time Frame: 5 years ] [ Designated as safety issue: No ]
To evaluate and understand the natural history of lymphedema during and after treatment for breast cancer [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	336
Study Start Date:	August 2009
Estimated Study Completion Date:	August 2014
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Group 1A Mild Lymphedema: Only required to meet with the lymphedema physical therapist
Active Comparator: Group 1B Mild Lymphedema: Fitted for compression sleeve	Device: Compression Sleeve Worn for a minimum of 12 hours per day
Active Comparator: Group 2A Moderate lymphedema: Fitted with a compression sleeve	Device: Compression Sleeve Worn for a minimum of 12 hours per day
Active Comparator: Group 2B Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage	Device: Compression Sleeve Worn for a minimum of 12 hours per day Device: Short-Stretch Compression Bandage Worn overnight at least 5 nights of the week

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959985

Contacts

Contact: Alphonse G. Taghian, MD, PhD

617-726-6050

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Alphonse G. Taghian, MD, PhD

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Alphonse Taghian, MD, PhD, Chief of Breast Service, Radiation Oncology, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00959985 History of Changes
Other Study ID Numbers:	08-308, R01CA139118
Study First Received:	August 14, 2009
Last Updated:	January 24, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

compression sleeve
compression bandage

Additional relevant MeSH terms:

Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms

Breast Diseases
Skin Diseases
Lymphatic Diseases

ClinicalTrials.gov processed this record on May 24, 2012