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

Trial Title: Manual Lymphatic Drainage Breast Massage in Breast Cancer Patients After Breast Conserving Surgery

NCT ID: NCT06297265

Condition: Anatomic Stage 0 Breast Cancer AJCC v8
Anatomic Stage IA Breast Cancer AJCC v8
Localized Breast Carcinoma

Conditions: Official terms:
Breast Neoplasms
Breast Carcinoma In Situ

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Lymphedema Management
Description: Undergo MLD breast massage
Arm group label: Supportive care (MLD breast massage)

Intervention type: Other
Intervention name: Questionnaire Administration
Description: Ancillary studies
Arm group label: Supportive care (MLD breast massage)

Intervention type: Radiation
Intervention name: Adjuvant breast radiation therapy
Description: 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.
Arm group label: Supportive care (MLD breast massage)

Other name: Radiotherapy

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 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 - 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 - Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants - 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 - Individuals who are cis male, transgender female and cis female without intact native breasts will be excluded

Gender: Female

Gender based: Yes

Gender description: Participants must be cis female with native breasts. Cis males, transgender females, and cis females without intact native breasts are excluded.

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: USC / Norris Comprehensive Cancer Center

Address:
City: Los Angeles
Zip: 90033
Country: United States

Status: Recruiting

Contact:
Last name: Kimberly Arieli, RN

Phone: 323-865-0451
Email: Kimberly.Arieli@med.usc.edu

Investigator:
Last name: May L. Tao, MD
Email: Principal Investigator

Start date: May 24, 2024

Completion date: May 24, 2027

Lead sponsor:
Agency: University of Southern California
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: University of Southern California

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06297265