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NCT Number: NCT06297265

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location status: Recruiting

Location contact

Kimberly Arieli, RN

CONTACT

[email protected]

323-865-0451

May L. Tao, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lymphedema Management

Other

Undergo MLD breast massage

Questionnaire Administration

Other

Ancillary studies

Adjuvant breast radiation therapy

Radiation

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.

Other names: Radiotherapy

Primary outcomes

  1. Rate of compliance of MLD breast massage sessions

    Time frame: Up to 1 month after completion of radiation

    The intervention compliance rate will be calculated as the percentage of completed treatment sessions over the total targeted treatment sessions.

Secondary outcomes

  1. Assess the effect of MLD breast massage breast edema

    Time frame: Up to 1 year

    The Dutch Breast Edema Questionnaire (BrEQ-Dutch version) will be used to diagnose the presence of breast edema. Getting 8.5 points from the questionnaire is the cut-off point. There is no breast edema below 8.5, there is breast edema above 8.5. It has a score between 0-80 points. Higher total symptom score means worse edema.

  2. Assess the effect of MLD breast massage on pain

    Time frame: Up to 1 year

    Pain will be graded using NCI-CTCAE version 5.0

  3. 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)

    Will be assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire. The FACT-B consists of 37 questions that address physical, social, emotional, and functional well-being. Each item has a score range of 0 (Not at all) to 4 (Very much), with a total score ranging from 0-148 The higher the score, the better the QOL reported by the participant.

  4. 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)

    Quality of Life will be assessed using the European Quality of Life 5 Dimension 5 Level (EuroQoL EQ-5D-5L) questionnaire. The questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems (1-5). The patient is asked to indicate her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. A higher score indicates more severe or frequent problems.

  5. 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)

    Will be assessed using the Body Image Scale (BIS). The 10-item Body Image Scale was developed by Hopwood et al. in 2001 to measure affective, behavioral, and cognitive body image symptoms. Patients can indicate body image symptoms on a 4-point scale (0 "not at all" to 3 "very much"). The total score ranges from 0 to 30 and can be calculated by summing up the 10 items. A higher score means a higher level of body image disturbance.

Study contacts

Contact information is provided by the study sponsor or research team.

Kimberly Arieli, RN

CONTACT

[email protected]

323-865-0451

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 7, 2024
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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