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

Last updated: December 12, 2024
Sponsor: University of Southern California
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Ductal Carcinoma In Situ (Dcis)

Treatment

Lymphedema Management

Adjuvant breast radiation therapy

Questionnaire Administration

Clinical Study ID

NCT06297265
1B-23-2
NCI-2023-10828
P30CA014089
1B-23-2
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female with native breasts and localized breast cancer who are statuspost-lumpectomy surgery, will receive whole breast radiation therapy with/withoutnodal irradiation, with standard fractionation or moderate hypofractionation

  • Age >= 18 years

  • Ability to understand and the willingness to sign a written informed consent inEnglish or Spanish

Exclusion

Exclusion Criteria:

  • Underlying diagnosis of chronic inflammatory illness or collagen vascular disorder,e.g. scleroderma, lupus, rheumatoid arthritis, fibromyalgia as these conditions maysignificantly affect the likelihood and magnitude of radiation related toxicity

  • Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, unstablecardiac arrhythmia, or psychiatric illness/social situations that would limitcompliance with study requirements

  • Patients must not be pregnant or nursing due to the potential for congenitalabnormalities 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 wallradiation therapy are excluded

  • Individuals who are cis male, transgender female and cis female without intactnative breasts will be excluded

Study Design

Total Participants: 50
Treatment Group(s): 3
Primary Treatment: Lymphedema Management
Phase:
Study Start date:
May 24, 2024
Estimated Completion Date:
May 24, 2027

Study 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.

Connect with a study center

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Active - Recruiting

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