RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Feasibility and Effects of Manual Lymphatic Drainage (MLD) Breast Massage in Breast Cancer Patients Undergoing Adjuvant Radiation Therapy

Quick Facts

Study Start:2024-05-24
Study Completion:2027-05-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06297265

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Cis 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
  2. * Age \>= 18 years
  3. * Ability to understand and the willingness to sign a written informed consent in English or Spanish
  1. * 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
  2. * 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
  3. * Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
  4. * Inability to provide written informed consent in English or Spanish
  5. * Patients receiving ultra-hypofractionation, and/or partial breast or chest wall radiation therapy are excluded
  6. * Individuals who are cis male, transgender female and cis female without intact native breasts will be excluded

Contacts and Locations

Study Contact

Kimberly Arieli, RN
CONTACT
323-865-0451
Kimberly.Arieli@med.usc.edu

Principal Investigator

May L Tao, MD
PRINCIPAL_INVESTIGATOR
University of Southern California

Study Locations (Sites)

USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States

Collaborators and Investigators

Sponsor: University of Southern California

  • May L Tao, MD, PRINCIPAL_INVESTIGATOR, University of Southern California

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-24
Study Completion Date2027-05-24

Study Record Updates

Study Start Date2024-05-24
Study Completion Date2027-05-24

Terms related to this study

Additional Relevant MeSH Terms

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