Acupuncture for Chronic Lymphedema

NCT01706081 | Completed Phase 2 Results

• 1 other identifier: 12-210
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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

Keywords

acupuncture

Outcome Measures

Primary Outcomes (1)

• Lymphedema as Measured at Baseline and at 6 Weeks

  Changes in lymphedema between groups, as measured by mean arm circumference assessed at baseline and after 6 weeks from baseline.

  6 weeks

Secondary Outcomes (2)

• Measurements for Bioimpedance for Treatment Arms at Baseline and 6 Weeks

  6 weeks

• Number of Participants Evaluated for Adverse Events

  1. 5 years

Study Arms (2)

Acupuncture

EXPERIMENTAL

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

Procedure: Acupuncture

Wait-list

EXPERIMENTAL

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

Procedure: Wait-list

Interventions

Acupuncture 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.

Acupuncture

Wait-list 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.

Wait-list

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Interventions

Acupuncture Therapy; Waiting Lists

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Appointments and Schedules; Organization and Administration; Health Services Administration

Results Point of Contact

• Title: Dr. Ting Bao MD
• Organization: Memorial Sloan Kettering Cancer Center

baot@mskcc.org

646-888-0865

Study Officials

• Ting Bao, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2012
• First Posted: October 15, 2012
• Study Start: October 1, 2012
• Primary Completion: April 11, 2018
• Study Completion: April 11, 2018
• Last Updated: August 29, 2019
• Results First Posted: August 29, 2019

Record last verified: 2018-04

Locations

US (1)