Acupuncture for Chronic Lymphedema

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01706081
First received: October 10, 2012
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer With Chronic Lymphedema
Procedure: Acupuncture
Procedure: Wait-list
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acupuncture for Chronic Lymphedema: A Randomized Wait-list Controlled Trial

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • difference in the extent of lymphedema [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The difference in the extent of lymphedema between groups will be assessed with an analysis of covariance (ANCOVA) model with extent of lymphedema after 6 weeks as the outcome with treatment group and baseline extent of lymphedema as covariates. We will report a two-tailed p-value and a 95% confidence interval for the difference between groups.

  • effectiveness [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    of acupuncture for the treatment of breast cancer-related lymphedema (BCRL) as measured by arm circumference after 6 weeks of acupuncture treatment.


Secondary Outcome Measures:
  • differences between treatment group for bioimpedance [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    ANCOVA models will be used to assess differences between treatment group for bioimpedance. The 6-week score will be the outcome and treatment group, baseline score, and randomization stratum will be included as covariates. We will report the two-tailed p-value and a 95% confidence interval for the difference between groups.

  • safety [ Time Frame: 1. 5 years ] [ Designated as safety issue: Yes ]
    Severity will be graded as "serious" or "non-serious". Serious AEs are those that require hospitalization, lead to death or disability or require urgent medical attention to prevent death or disability. The intensity of non-serious AEs will be graded as mild, moderate or severe.


Estimated Enrollment: 82
Study Start Date: October 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture
Patients in the acupuncture group will receive acupuncture treatment twice weekly for six consecutive weeks.
Procedure: 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.
Experimental: Wait-list
Patients in the wait-list control group will cross over and receive acupuncture twice weekly for 6 consecutive weeks.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706081

Contacts
Contact: Barrie Cassileth, PhD 646-888-0801
Contact: Kimberly VanZee, MD 646-888-5241

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Barrie Cassileth, PhD    646-888-0801      
Contact: Kimberly Van Zee, MD    646-888-5241      
Principal Investigator: Barrie Cassileth, PhD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Barrie Cassileth, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01706081     History of Changes
Other Study ID Numbers: 12-210
Study First Received: October 10, 2012
Last Updated: August 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
acupuncture

Additional relevant MeSH terms:
Lymphedema
Breast Neoplasms
Lymphatic Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014