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

University of Southern California

Status

Enrolling

Conditions

Anatomic Stage IA Breast Cancer AJCC V8

Anatomic Stage 0 Breast Cancer AJCC V8

Localized Breast Carcinoma

Treatments

Other: Lymphedema Management

Radiation: Adjuvant breast radiation therapy

Other: Questionnaire Administration

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06297265

P30CA014089 (U.S. NIH Grant/Contract)

1B-23-2 (Other Identifier)

NCI-2023-10828 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

50 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
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
Individuals who are cis male, transgender female and cis female without intact native breasts will be excluded