NCT06297265 Manual Lymphatic Drainage Breast Massage in Breast Cancer Patients After Breast Conserving Surgery
| NCT ID | NCT06297265 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Southern California |
| Condition | Anatomic Stage 0 Breast Cancer AJCC v8 |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-05-24 |
| Primary Completion | 2026-05-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-05-24 with a primary completion date of 2026-05-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
May L Tao, MD
PRINCIPAL INVESTIGATOR
University of Southern California
Frequently Asked Questions
Who can join the NCT06297265 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Anatomic Stage 0 Breast Cancer AJCC v8. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06297265 currently recruiting?
Yes, NCT06297265 is actively recruiting participants. Contact the research team at Kimberly.Arieli@med.usc.edu for enrollment information.
Where is the NCT06297265 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT06297265 clinical trial?
NCT06297265 is sponsored by University of Southern California. The principal investigator is May L Tao, MD at University of Southern California. The trial plans to enroll 50 participants.
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