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Acupuncture for Chronic Lymphedema

Primary Purpose

Breast Cancer With Chronic Lymphedema

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Wait-list
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer With Chronic Lymphedema focused on measuring acupuncture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Acupuncture

Wait-list

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Number of Participants Evaluated for Adverse Events

Full Information

First Posted
October 10, 2012
Last Updated
July 24, 2019
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01706081
Brief Title
Acupuncture for Chronic Lymphedema
Official Title
Acupuncture for Chronic Lymphedema: A Randomized Wait-list Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
April 11, 2018 (Actual)
Study Completion Date
April 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer With Chronic Lymphedema
Keywords
acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
Patients in the acupuncture group will receive acupuncture treatment twice weekly for six consecutive weeks.
Arm Title
Wait-list
Arm Type
Experimental
Arm Description
Patients in the wait-list control group will cross over and receive acupuncture twice weekly for 6 consecutive weeks.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
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
Intervention Name(s)
Wait-list
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lymphedema as Measured at Baseline and at 6 Weeks
Description
Changes in lymphedema between groups, as measured by mean arm circumference assessed at baseline and after 6 weeks from baseline.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Measurements for Bioimpedance for Treatment Arms at Baseline and 6 Weeks
Description
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.
Time Frame
6 weeks
Title
Number of Participants Evaluated for Adverse Events
Time Frame
1. 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ting Bao, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

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Acupuncture for Chronic Lymphedema

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