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

NCT ID: NCT06297265

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-24
• Study Completion Date: 2027-05-24

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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supportive care (MLD breast massage)

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

Group Type: EXPERIMENTAL

Lymphedema Management

Intervention Type: OTHER

Undergo MLD breast massage

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Adjuvant breast radiation therapy

Intervention Type: 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.

Interventions

Lymphedema Management

Undergo MLD breast massage

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Adjuvant breast radiation therapy

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.

Intervention Type: RADIATION

Other Intervention Names

Radiotherapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

May L Tao, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kimberly Arieli, RN

Role: CONTACT

Phone: 323-865-0451

Email: Kimberly.Arieli@med.usc.edu

Facility Contacts

Kimberly Arieli, RN

Role: primary

Other Identifiers

NCI-2023-10828

Identifier Type: REGISTRY

Identifier Source: secondary_id

1B-23-2

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA014089

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1B-23-2

Identifier Type: -

Identifier Source: org_study_id