Recruiting

Manual Lymphatic Drainage

Sponsor:

University of Southern California

Code:

NCT06297265

Conditions

Anatomic Stage 0 Breast Cancer AJCC v8

Anatomic Stage IA Breast Cancer AJCC v8

Localized Breast Carcinoma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lymphedema Management

Questionnaire Administration

Adjuvant breast radiation therapy

Study Details

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

Study ID

NCT06297265

Start date

May 24, 2024

Status verified date

May, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Lymphedema Management

Undergo MLD breast massage

Questionnaire Administration

Ancillary studies

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.

Primary outcome measure

  • Rate of compliance of MLD breast massage sessions [ Time Frame: Up to 1 month after completion of radiation ]

Central Contacts and Locations

Central contacts

Kimberly Arieli, RN

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

Locations

USC / Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Kimberly Arieli, RN

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

Principal Investigator:

May L. Tao, MD

More Information

Sponsor

University of Southern California

Last update posted

Jun 5, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-06-05.