Effectiveness of Acupuncture for Breast Cancer Related Lymphedema (Acupuncture)

November 21, 2016 updated by: Fourth Affiliated Hospital of Guangxi Medical University
This multicenter placebo-controlled trial focuses on the efficacy and safety of acupuncture on breast-cancer related lymphedema. 200 participants will be recruited, and randomized in two groups: the real acupuncture group and the sham acupuncture group.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In the theory of Traditional Chinese Medicine (TCM), Breast Cancer Related Lymphedema (BCRL) is classified as "edema", and is considered to be caused by qi (chi) deficiency and blood stagnation. Acupuncture, as an ancient therapy in TCM, is thought to have the efficacy to stimulate the transformation of qi and drainage of dampness, and is widely used for various diseases including edema in China. Early clinical trials as well as our own clinical observation have demonstrated that acupuncture can ameliorate limb swelling and decrease lymphedema. However, no randomized placebo-controlled trial has been performed to evaluate this efficacy of acupuncture. Therefore, this study aimed to evaluate the safety and potential efficacy of acupuncture to treat chronic upper-limb lymphedema.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Zheng Peng
  • Phone Number: +86 772 3840144
  • Email: 1371@sina.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women who completed all primary and adjuvant treatments.
  • age between 20 and 45.
  • BMI between 18 and 28.
  • unilateral lymphedema resulting from surgery for breast cancer.
  • mild to moderate lymphedema, with 10% to 40% increase in volume compared to the unaffected arm based on perometry evaluation.
  • with no evidence of recurrence.

Exclusion Criteria:

  • bilateral lymphedema.
  • history of bilateral axillary lymph node dissection.
  • serious lymphedema, with over 40% increase in volume compared to the unaffected arm based on perometry evaluation.
  • pregnant women.
  • unable to adhere to the protocol or the treatment schedule.
  • recurrent breast cancer or other malignancies.
  • current use of chemotherapy or radiation.
  • current use of diuretic drugs like Diosmin, or other investigational drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Real acupuncture group
Patients in the real acupuncture group will receive true acupuncture 3 times a week for 4 weeks (12 sessions). A standardized prescription of six acupuncture points is used unilaterally. Needles are inserted and manipulated manually until needling sensation (de qi) is obtained, and are retained for 20 minutes with manual manipulation at 10 minutes. Acupuncturists are trained to inquire about specific needle sensations when providing true acupuncture.
Device: acupuncture
Acupuncture involves the insertion of extremely thin needles through skin at strategic points on human body. Many Western practitioners view the acupuncture as a device to stimulate nerves, muscles and connective tissue, and believe that it can increases blood flow.
Other Names:
  • zhen jiu
Sham Comparator: Sham acupuncture group
Patients in the sham acupuncture group will receive sham acupuncture 3 times a week for 4 weeks (12 sessions).
Device: acupuncture
Acupuncture involves the insertion of extremely thin needles through skin at strategic points on human body. Many Western practitioners view the acupuncture as a device to stimulate nerves, muscles and connective tissue, and believe that it can increases blood flow.
Other Names:
  • zhen jiu

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute Reduced Limb Volume Ratio
Time Frame: Day 0 (baseline), Day 30(endpoint)

Data of the absolute limb volume will be collected before the treatment (volume at baseline, B) and after the treatment (volume after therapy, A) for every participant. VL is the volume of the affected arm with lymphedema, and VC is the volume of the contralateral arm. Then, The ARLVR will be calculated using the following formula: ARLVR (%) = (VL-Vc)B-( VL-Vc)A/( VL-Vc)B ×100%.

The arm measurement will be conducted using perometer. This method is inspired by the method established by Anderson et al.
Day 0 (baseline), Day 30(endpoint)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Event
Time Frame: Day 0 (baseline), Day 30(endpoint)
Every adverse event during the treatment will be recorded, unless it is confirmed otherwise, whereas those occurs after the treatment will not be calculate unless it is confirmed.
Day 0 (baseline), Day 30(endpoint)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fourth Affiliated Hospital of Guangxi Medical University

Collaborators

Liuzhou Maternity and Child Healthcare Hospital
Liuzhou Hospital of Traditional Chinese Medicine

Investigators

  • Principal Investigator: Xiangcheng Wei, Guangxi Medical University Institutional Review Board

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

June 14, 2016

First Submitted That Met QC Criteria

June 14, 2016

First Posted (Estimate)

June 17, 2016

Study Record Updates

Last Update Posted (Estimate)

November 23, 2016

Last Update Submitted That Met QC Criteria

November 21, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PJK201690

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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