Manual Lymphatic Drainage Breast Massage in Breast Cancer Patients After Breast Conserving Surgery

Feasibility and Effects of Manual Lymphatic Drainage (MLD) Breast Massage in Breast Cancer Patients Undergoing Adjuvant Radiation Therapy

This phase II trial evaluates manual lymphatic drainage breast massage for reducing treatment-related side effects in women undergoing radiation therapy after breast conserving surgery for breast cancer that has not spread to other parts of the body (localized). Breast conserving surgery can be an effective treatment option for early stage breast cancer, but it can also be associated with side effects including fluid collection in tissues/swelling (lymphedema), pain, reduced quality of life, and poorer body image. Manual lymphatic drainage is a gentle massage technique used to reduce swelling. It may be a safe and effective way to reduce treatment-related side effects in women receiving radiation therapy after surgery for localized breast cancer.

PRIMARY OBJECTIVE:

I. Evaluate the feasibility of breast manual lymphatic drainage (MLD) on breast cancer patients receiving adjuvant breast radiation therapy after breast conserving surgery.

SECONDARY OBJECTIVES:

I. Evaluate the tolerability of breast manual lymphatic drainage (MLD) on breast cancer patients receiving adjuvant breast radiation therapy after breast conserving surgery.

II. Preliminarily assess the effect on acute and chronic breast edema, pain, functional status, quality of life, body image and radiation induced fibrosis (RIF).

OUTLINE:

Patients undergo MLD breast massage over 30-60 minutes twice a week (BIW) for the duration of standard of care (SOC) radiation therapy and for 1 month thereafter.

After completion of SOC radiation therapy, patients are followed up at 2-4 weeks and 3, 6, and 12 months.

Inclusion Criteria:

• Female with native breasts and localized breast cancer who are status post-lumpectomy surgery, will receive whole breast radiation therapy with/without nodal irradiation, with standard fractionation or moderate hypofractionation
• Age >= 18 years
• Ability to understand and the willingness to sign a written informed consent in English or Spanish

Exclusion Criteria:

• Underlying diagnosis of chronic inflammatory illness or collagen vascular disorder, e.g. scleroderma, lupus, rheumatoid arthritis, fibromyalgia as these conditions may significantly affect the likelihood and magnitude of radiation related toxicity
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Inability to provide written informed consent in English or Spanish
• Patients receiving ultra-hypofractionation, and/or partial breast or chest wall radiation therapy are excluded