Breast Cancer With Chronic Lymphedema Clinical Trial
Official title:
Acupuncture for Chronic Lymphedema: A Randomized Wait-list Controlled Trial
| NCT number | NCT01706081 |
| Other study ID # | 12-210 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | October 2012 |
| Est. completion date | April 11, 2018 |
| Verified date | April 2018 |
| Source | Memorial Sloan Kettering Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 82 |
| Est. completion date | April 11, 2018 |
| Est. primary completion date | April 11, 2018 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Memorial Sloan Kettering Cancer Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Measurements for Bioimpedance for Treatment Arms at Baseline and 6 Weeks | Bioimpedance measured using Impedimed L-Dex U400, which measures the rate of electrical current transmission through tissues and estimate fluid content in a lymphedematous limb compared with the normal limb. | 6 weeks | |
| Secondary | Number of Participants Evaluated for Adverse Events | 1. 5 years |