Acupuncture for Chronic Lymphedema

NCT ID: NCT01706081

Last Updated: 2019-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2018-04-11

Brief Summary

This study is being done because women have arm swelling for more than 6 months despite wrapping and other treatments. This swelling is called lymphedema. It is the back up of lymph system fluid that causes swelling in the arm. The swelling can just happen, but more commonly it is caused when lymph nodes are removed during cancer surgery. It can develop right after breast cancer treatment or weeks, months or even years later. In our preliminary research, the investigators found that more than 1/3 of the 33 patients showed at least a 30% reduction in lymphedema following acupuncture treatment and there were no serious adverse events during the treatment or 6 month followup.

This study will include a larger group of patients. Patients will be assigned to one of two groups, and results of the groups will be compared to see if acupuncture can reduce lymphedema and whether the effect lasts after acupuncture treatment is completed.

Conditions

Breast Cancer With Chronic Lymphedema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acupuncture

Patients in the acupuncture group will receive acupuncture treatment twice weekly for six consecutive weeks.

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: PROCEDURE

Each treatment will be 30 minutes in duration. Patients will receive two acupuncture treatments each week for six consecutive weeks. Patients will be advised to continue their standard lymphedema treatments such as exercise or use of compression garments if these were in use prior to clinical trial participation.

Wait-list

Patients in the wait-list control group will cross over and receive acupuncture twice weekly for 6 consecutive weeks.

Group Type: EXPERIMENTAL

Wait-list

Intervention Type: PROCEDURE

For participants in the wait-list control group, follow-up objective and subjective assessments of lymphedema will be performed after approximately 6 weeks on the wait-list, before onset of acupuncture treatment, following 6 weeks of acupuncture treatment and about 3 months after completion of treatment. BMI will be measured at the same timepoints.

Interventions

Acupuncture

Each treatment will be 30 minutes in duration. Patients will receive two acupuncture treatments each week for six consecutive weeks. Patients will be advised to continue their standard lymphedema treatments such as exercise or use of compression garments if these were in use prior to clinical trial participation.

Intervention Type: PROCEDURE

Wait-list

For participants in the wait-list control group, follow-up objective and subjective assessments of lymphedema will be performed after approximately 6 weeks on the wait-list, before onset of acupuncture treatment, following 6 weeks of acupuncture treatment and about 3 months after completion of treatment. BMI will be measured at the same timepoints.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Women age 18 or older
• Lymphedema in an arm as a result of surgery, chemotherapy, and/or radiation therapy for breast cancer per breast surgeon or medical oncologist
• Patients must have received a clinical diagnosis of lymphedema for at least 6 months and no more than 5 years. This timeframe allows ample time for any surgically related non lymphedema swelling to subside by 6 months post-surgery, while a cap of 5 years will capture the broadest range of cases, and has been used as a timeframe in several studies including our pilot study.
• The affected arm must be >2cm larger than the unaffected arm. Differences of 2 cm or more between the affected and unaffected arm are considered by experts to be clinically significant. Each affected arm will be measured in two areas: upper arm and forearm.

The larger of the two measures-upper arm or forearm- will be used for analysis.

• Classified as International Society of Lymphology (ISL) stage II or higher as determined by an MSKCC Certified Lymphedema Therapist (CLT).

Exclusion Criteria

• Bilateral lymphedema
• Previous acupuncture treatment for lymphedema
• Concurrent diuretic use
• History of primary (congenital) lymphedema
• Pregnant or planning to become pregnant during the course of the study
• Has an implanted electronically charged medical device

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ting Bao, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

12-210

Identifier Type: -

Identifier Source: org_study_id