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Recruiting NCT06297265

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

No phase Interventional Anatomic Stage 0 Breast Cancer AJCC v8 Anatomic Stage IA Breast Cancer AJCC v8 Localized Breast Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lymphedema Management, Questionnaire Administration, Adjuvant breast radiation therapy.
Who it may be relevant to
Registry conditions: Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Localized Breast Carcinoma. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other Lymphedema Management
    Undergo MLD breast massage
  • Other Questionnaire Administration
    Ancillary studies
  • Radiation Adjuvant breast radiation therapy
    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.

Primary outcome measures

  • Rate of compliance of MLD breast massage sessions [Time frame: Up to 1 month after completion of radiation]
Secondary outcome measures (5)
  • Assess the effect of MLD breast massage breast edema [Time frame: Up to 1 year]
  • Assess the effect of MLD breast massage on pain [Time frame: Up to 1 year]
  • Assess the effect of MLD breast massage on functional status [Time frame: From baseline to follow-up (2-4 weeks, and 3, 6, and 12 months)]
  • Assess the effect of MLD breast massage on quality of life [Time frame: From baseline to follow-up (2-4 weeks, and 3, 6, and 12 months)]
  • Assess the effect of MLD breast massage on body image [Time frame: From baseline to follow-up (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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • USC / Norris Comprehensive Cancer Center — Los Angeles

Identifiers

NCT: NCT06297265 · 1B-23-2 · NCI-2023-10828 · 1B-23-2 · P30CA014089

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗