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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00959985
• Other study ID #: 08-308
• Secondary ID: R01CA139118
• Status: Terminated
• Phase: Phase 3
• First received: August 14, 2009
• Last updated: March 14, 2016
• Start date: August 2009
• Est. completion date: August 2014

Study information

• Verified date: March 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymphedema

Intervention

Device:
• Compression Sleeve
Worn for a minimum of 12 hours per day
• Short-Stretch Compression Bandage
Worn overnight at least 5 nights of the week

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the efficacy of early intervention using compression garments for low volume lymphedema associated with breast cancer treatment.		5 years	No
Primary	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.		5 years	No
Primary	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.		5 years	No
Secondary	To identify risk factors associated with the onset of lymphedema that are both related and unrelated to treatment for breast cancer		5 years	No
Secondary	To evaluate and understand the natural history of lymphedema during and after treatment for breast cancer		5 years	No