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.
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
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
Single group
Lymphedema Management
Other interventionUndergo MLD breast massage
Questionnaire Administration
Other interventionAncillary studies
Adjuvant breast radiation therapy
RadiationUsing standard 3D conformal or intensity modulated techniques, patients will receive standard fractionation or moderate hypofractionation radiation therapy. The radiation treatment will last for 3 to 6 weeks, with the length of treatment depending on patient's specific clinical situation.
Rate of compliance of MLD breast massage sessions
The intervention compliance rate will be calculated as the percentage of completed treatment sessions over the total targeted treatment sessions.
Assess the effect of MLD breast massage breast edema
The Dutch Breast Edema Questionnaire (BrEQ-Dutch version) will be used to diagnose the presence of breast edema. Getting 8.5 points from the questionnaire is the cut-off point. There is no breast edema below 8.5, there is breast edema above 8.5. It has a score between 0-80 points. Higher total symptom score means worse edema.
Assess the effect of MLD breast massage on pain
Pain will be graded using NCI-CTCAE version 5.0
Assess the effect of MLD breast massage on functional status
Will be assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire. The FACT-B consists of 37 questions that address physical, social, emotional, and functional well-being. Each item has a score range of 0 (Not at all) to 4 (Very much), with a total score ranging from 0-148 The higher the score, the better the QOL reported by the participant.
Assess the effect of MLD breast massage on quality of life
Quality of Life will be assessed using the European Quality of Life 5 Dimension 5 Level (EuroQoL EQ-5D-5L) questionnaire. The questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems (1-5). The patient is asked to indicate her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. A higher score indicates more severe or frequent problems.
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University of Southern California
Lead sponsor
National Cancer Institute (NCI)
Collaborator
