Lymphatic Drainage Massage for Breast Cancer

Overseen By Kimberly Arieli, RN

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Chronic inflammatory illness, Uncontrolled illness, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: Up to 1 month after completion of radiation

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Manual Lymphatic Drainage for breast cancer-related conditions?

Research shows that Manual Lymphatic Drainage (MLD) is commonly used for managing lymphedema (swelling due to fluid build-up) after breast cancer surgery, but its effectiveness is debated. Some studies suggest it may help reduce swelling, while others find the benefits unclear. ^{1 2 3 4 5}

Is manual lymphatic drainage massage safe for humans?

Manual lymphatic drainage (MLD) massage is generally considered safe for humans, as it is widely used for conditions like lymphedema, especially after breast cancer surgery. However, the effectiveness of MLD can vary, and it is important to consult with a healthcare provider before starting any new treatment. ^{1 2 4 5 6}

How does lymphatic drainage massage differ from other treatments for breast cancer-related lymphedema?

Lymphatic drainage massage is a hands-on technique that helps move lymph fluid (a clear fluid that circulates through the lymphatic system) to reduce swelling, which is different from other treatments that might involve medication or surgery. It is a non-invasive option that focuses on improving fluid circulation through gentle massage, making it unique compared to more aggressive treatments. ^{1 2 3 4 6}

What is the purpose of this trial?

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.

Research Team

May L Tao, MD

Principal Investigator

University of Southern California

Eligibility Criteria

This trial is for women with localized breast cancer who have undergone breast conserving surgery and are receiving radiation therapy. It aims to help those experiencing side effects like lymphedema, pain, and body image concerns.

Inclusion Criteria

I am a woman who has had a lumpectomy for breast cancer and will get radiation therapy.

I can understand and am willing to sign the consent form in English or Spanish.

Exclusion Criteria

I have a chronic inflammatory or autoimmune condition like lupus or rheumatoid arthritis.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo MLD breast massage over 30-60 minutes twice a week for the duration of standard of care radiation therapy and for 1 month thereafter

Up to 1 month after completion of radiation

Twice a week

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 1 year

Follow-up at 2-4 weeks and 3, 6, and 12 months

Treatment Details

Interventions

• Manual Lymphatic Drainage Breast Massage

Trial Overview The study is testing manual lymphatic drainage, a gentle massage technique designed to reduce swelling and other side effects from radiation therapy after breast conserving surgery in early stage breast cancer patients.

Participant Groups

Group I: Supportive care (MLD breast massage) Experimental Treatment 3 Interventions

Patients undergo MLD breast massage over 30-60 minutes BIW for the duration of SOC radiation therapy and for 1 month thereafter.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A randomized controlled trial involving 160 adults who underwent unilateral axillary dissection for breast cancer found that manual lymph drainage (MLD) did not significantly reduce the incidence of lymphoedema compared to a control group receiving only exercise therapy and information.

After 60 months, the cumulative incidence rates of lymphoedema were similar between the experimental group (MLD) and the control group, indicating that MLD may not provide a preventive benefit for developing lymphoedema in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manual lymph drainage may not have a preventive effect on the development of breast cancer-related lymphoedema in the long term: a randomised trial. Devoogdt, N., Geraerts, I., Van Kampen, M., et al.[2019]

In a study involving 457 patients, manual lymphatic drainage (MLD) did not show a significant overall reduction in upper extremity edema compared to no treatment, indicating its efficacy remains uncertain.

However, when patients received 20 or more MLD sessions or underwent treatment for more than 2 weeks, there was a significant reduction in limb volume, suggesting that the effectiveness of MLD may depend on the treatment duration and frequency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Manual Lymphatic Drainage on Breast Cancer-Related Postmastectomy Lymphedema: A Meta-analysis of Randomized Controlled Trials. Qiao, J., Yang, LN., Kong, YH., et al.[2023]

Manual lymphatic drainage (MLD) significantly reduces pain intensity in breast cancer-related lymphedema (BCRL) patients, based on a meta-analysis of 11 randomized controlled trials involving 1564 participants.

While MLD shows promise in reducing the incidence of lymphedema, it does not significantly improve volumetric changes of lymphedema or quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manual Lymphatic Drainage for Breast Cancer-related Lymphedema: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Lin, Y., Yang, Y., Zhang, X., et al.[2022]

Manual lymphatic drainage (MLD) massage may help reduce the incidence of lymphedema in patients at-risk, particularly after breast cancer surgery, but results are mixed and more research is needed.

In cases of mild lymphedema, MLD can contribute to volume reduction, but it does not seem to offer additional benefits when used alongside complex decongestive therapy for moderate to severe lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manual lymphatic drainage treatment for lymphedema: a systematic review of the literature. Thompson, B., Gaitatzis, K., Janse de Jonge, X., et al.[2021]

A systematic review of 10 randomized controlled trials found insufficient evidence to support that manual lymphatic drainage (MLD) effectively reduces the risk of breast cancer-related lymphedema (BCRL) in women after breast surgery.

While MLD may help manage existing BCRL by reducing arm volume, its effectiveness is similar whether used alone or in combination with other treatments, indicating a need for more rigorous studies to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manual Lymphedema Drainage for Reducing Risk for and Managing Breast Cancer-Related Lymphedema After Breast Surgery: A Systematic Review. Wanchai, A., Armer, JM.[2021]

A study involving 66 women with breast cancer-related lymphedema showed that manual lymphatic therapy (MLT) significantly reduced limb volume after treatment, indicating its effectiveness in preventing lymphedema progression.

The results were statistically significant (p-value = 0.0001), demonstrating that MLT can be a beneficial intervention immediately following breast cancer surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of Arm Lymphedema Using Manual Lymphatic Therapy (Godoy Method). Pereira de Godoy, JM., Pereira de Godoy, LM., Pereira de Godoy, HJ., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Manual lymph drainage may not have a preventive effect on the development of breast cancer-related lymphoedema in the long term: a randomised trial. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of Manual Lymphatic Drainage on Breast Cancer-Related Postmastectomy Lymphedema: A Meta-analysis of Randomized Controlled Trials. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Manual Lymphatic Drainage for Breast Cancer-related Lymphedema: A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Manual lymphatic drainage treatment for lymphedema: a systematic review of the literature. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Manual Lymphedema Drainage for Reducing Risk for and Managing Breast Cancer-Related Lymphedema After Breast Surgery: A Systematic Review. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Reduction of Arm Lymphedema Using Manual Lymphatic Therapy (Godoy Method). [2022]