Clinical trial NCT06297265: Manual Lymphatic Drainage Breast Massage in Breast Cancer Patients After Breast Conserving Surgery
Official title: Feasibility and Effects of Manual Lymphatic Drainage (MLD) Breast Massage in Breast Cancer Patients Undergoing Adjuvant Radiation Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anatomic Stage 0 Breast Cancer AJCC v8
Anatomic Stage IA Breast Cancer AJCC v8
Localized Breast Carcinoma
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-03-07
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Rate of compliance of MLD breast massage sessions
timeFrame: Up to 1 month after completion of radiation
Secondary outcomes:
measure: Assess the effect of MLD breast massage breast edema
timeFrame: Up to 1 year
measure: Assess the effect of MLD breast massage on pain
timeFrame: Up to 1 year
measure: Assess the effect of MLD breast massage on functional status
timeFrame: From baseline to follow-up (2-4 weeks, and 3, 6, and 12 months)
measure: Assess the effect of MLD breast massage on quality of life
timeFrame: From baseline to follow-up (2-4 weeks, and 3, 6, and 12 months)
measure: Assess the effect of MLD breast massage on body image
timeFrame: From baseline to follow-up (2-4 weeks, and 3, 6, and 12 months)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: May L Tao, MD
role: PRINCIPAL_INVESTIGATOR
References: