Breast massage to reduce side effects in breast cancer patients after surgery
Feasibility and Effects of Manual Lymphatic Drainage (MLD) Breast Massage in Breast Cancer Patients Undergoing Adjuvant Radiation Therapy
NA · University of Southern California · NCT06297265
This study tests whether breast massage can help women with breast cancer feel better and reduce side effects during and after radiation therapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Southern California (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06297265 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of manual lymphatic drainage breast massage in women undergoing radiation therapy after breast conserving surgery for localized breast cancer. The primary goal is to assess the feasibility of this massage technique in reducing treatment-related side effects such as lymphedema, pain, and impaired quality of life. Participants will receive the massage twice a week during radiation therapy and for one month afterward, with follow-up assessments at various intervals to evaluate outcomes. The study aims to provide insights into the tolerability and potential benefits of this intervention.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with localized breast cancer who have undergone lumpectomy and are scheduled to receive radiation therapy.
Not a fit: Patients with chronic inflammatory illnesses or uncontrolled intercurrent conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly alleviate treatment-related side effects and improve the quality of life for breast cancer patients.
How similar studies have performed: While similar approaches have been explored, this specific application of manual lymphatic drainage in the context of breast cancer treatment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California
- USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States (RECRUITING)
Study contacts
- Principal investigator: May L Tao, MD — University of Southern California
- Study coordinator: Kimberly Arieli, RN
- Email: Kimberly.Arieli@med.usc.edu
- Phone: 323-865-0451
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Localized Breast Carcinoma