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

NCT06297265 | Recruiting DMC FDA Device

• 3 other identifiers: 1B-23-2NCI-2023-10828P30CA014089
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anatomic Stage 0 Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Localized Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 1 month after completion of radiation

Secondary Outcomes (5)

• Assess the effect of MLD breast massage breast edema

  Up to 1 year

• Assess the effect of MLD breast massage on pain

  Up to 1 year

• Assess the effect of MLD breast massage on functional status

  From baseline to follow-up (2-4 weeks, and 3, 6, and 12 months)

• Assess the effect of MLD breast massage on quality of life

  From baseline to follow-up (2-4 weeks, and 3, 6, and 12 months)

• Assess the effect of MLD breast massage on body image

  From baseline to follow-up (2-4 weeks, and 3, 6, and 12 months)

Study Arms (1)

Supportive care (MLD breast massage)

EXPERIMENTAL

Patients undergo MLD breast massage over 30-60 minutes BIW for the duration of SOC radiation therapy and for 1 month thereafter.

Other: Lymphedema Management; Other: Questionnaire Administration; Radiation: Adjuvant breast radiation therapy

Interventions

Lymphedema Management OTHER

Undergo MLD breast massage

Supportive care (MLD breast massage)

Adjuvant breast radiation therapy RADIATION

Using 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.

Also known as: Radiotherapy

Supportive care (MLD breast massage)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (MLD breast massage)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants must be female with native breasts. Cis males, transgender females, and cis females without intact native breasts are excluded.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

MeSH Terms

Conditions

Breast Carcinoma In Situ

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• May L Tao, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly Arieli, RN

CONTACT

323-865-0451; Kimberly.Arieli@med.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: March 7, 2024
• Study Start: May 24, 2024
• Primary Completion (Estimated): May 24, 2026
• Study Completion (Estimated): May 24, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (1)