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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a type of gentle massage, called manual lymphatic drainage, can alleviate side effects for women undergoing radiation therapy after breast surgery for early-stage breast cancer. This massage may reduce swelling, pain, and other treatment-related discomforts. Women who have had surgery to remove breast cancer, still have intact breasts, and are about to start or are currently receiving radiation therapy might be suitable candidates. The trial aims to determine if this massage improves their quality of life during and after treatment. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance comfort and quality of life for future patients.

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 prior data suggests that manual lymphatic drainage breast massage is safe for reducing treatment-related side effects?

Research has shown that manual lymphatic drainage (MLD) breast massage is generally safe and well-tolerated. Studies have found it effective in reducing pain and swelling from breast cancer treatments. These studies report no major harmful side effects from MLD. This gentle massage technique has successfully alleviated symptoms like lymphedema, a type of swelling often experienced after breast cancer surgery. Overall, MLD appears to be a safe option for managing side effects in breast cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for breast cancer, which often focus on chemotherapy, radiation, and surgery to target the cancer itself, Manual Lymphatic Drainage (MLD) breast massage is unique because it aims to support the body's natural lymphatic system. This technique involves gentle, rhythmic massage to promote lymph flow and reduce swelling, which can be a common side effect of breast cancer treatments. Researchers are excited about MLD because it offers a non-invasive, supportive care option that can be used alongside standard treatments to potentially improve patient comfort and recovery without the need for additional medication.

What evidence suggests that manual lymphatic drainage breast massage is effective for reducing side effects in breast cancer treatment?

Research has shown that manual lymphatic drainage (MLD) massage can reduce swelling caused by fluid build-up after breast cancer surgery. Studies have found MLD effective at reducing both swelling and pain, common side effects of breast cancer treatments. A review of multiple studies found that MLD also lowers the risk of developing swelling and helps relieve pain. MLD has proven more effective than simpler methods for managing swelling. Overall, MLD massage appears promising for improving the quality of life for breast cancer patients by managing treatment side effects.

In this trial, participants will receive supportive care with MLD breast massage to evaluate its effectiveness during and after standard-of-care radiation therapy. ^{4 6 7 8 9}

Who Is on the Research Team?

May L Tao, MD

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

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

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

Exclusion Criteria

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7717855/

Manual lymphatic drainage for lymphedema in patients after ... Studies have shown that manual lymphatic drainage (MLD) has a beneficial effect on lymphedema related to breast cancer surgery.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0031940605609339

Manual Lymphatic Drainage Compared with Simple ... The results of this small pilot study suggest that MLD is more effective than SLD in treating post-mastectomy arm lymphoedema.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38051428/

Effectiveness of manual lymphatic drainage in intensive ... We showed a strong effect of MLD on volume reduction. Differences from other studies are the larger study population and the more intensive ...

4. ejgo.net ejgo.net/articles/10.22514/ejgo.2023.001

Effectiveness of manual lymphatic drainage for breast ... The results indicated that MLD could significantly reduce lymphedema in patients aged <60 years (standard mean difference (SMD): −1.77, 95% confidence interval ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1526820922000349

Manual Lymphatic Drainage for Breast Cancer-related ... The results of this meta-analysis revealed that MLD had a positive effect on the pain relief of BCRL patients as well as on reducing the incidence of lymphedema ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25994425/

Manual lymphatic drainage for lymphedema following breast ... MLD was well tolerated and safe in all trials.Two trials measured function as range of motion with conflicting results. One trial reported ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35370085/

Manual Lymphatic Drainage for Breast Cancer-related ... The purpose of this systematic review was to meta-analyze the effectiveness of manual lymphatic drainage (MLD) in breast cancer-related lymphedema (BCRL) ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06297265?term=AREA%5BConditionSearch%5D(Metachromatic%20leukodystrophy%20OR%20%22arylsulfatase%20A%20deficiency%22%20OR%20%22%20deficiency%20of%20cerebroside-sulfatase%22%20OR%20%22%20MLD%22%20OR%20%22%20Scholz%20cerebral%20sclerosis%22%20OR%20%22%20sulfatide%20lipoidosis%22)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING)&rank=10

Manual Lymphatic Drainage Breast Massage in ... 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.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06750679

The Effect of Manual Lymph Drainage Applied As an ... Manual Lymphatic Drainage May Not Have an Additional Effect on the Intensive Phase of Breast Cancer-Related Lymphedema: A Randomized Controlled Trial.