RightFit
RecruitingNot applicable

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 month

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a gentle breast massage to reduce swelling can ease side effects from breast cancer treatment. It is for women with breast cancer that has not spread to other parts of the body who will receive radiation after surgery that removes the cancer but keeps the breast.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women age 18 or older with their natural breasts and breast cancer that has not spread to other parts of the body.
  • Have had a lumpectomy, surgery to remove the cancer while keeping the breast.
  • Will receive radiation to the whole breast, with or without radiation to nearby lymph nodes.
  • Will receive a standard radiation schedule or a somewhat shorter schedule with larger doses per visit.
  • Can understand and are willing to sign a written consent form in English or Spanish.

Who can't join

  • Have a long-term inflammatory or connective tissue condition, such as scleroderma, lupus, rheumatoid arthritis, or fibromyalgia.
  • Have an uncontrolled illness, such as an active infection, heart failure with symptoms, unstable chest pain, or an unstable heartbeat.
  • Have a mental health condition or life situation that would make it hard to follow study requirements.
  • Cannot give written consent in English or Spanish.
  • Will receive a very short radiation schedule with much larger doses per visit, or radiation to only part of the breast or the chest wall.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

CA