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.
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.
|
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:
|
|
Sham Comparator: Sham acupuncture group
Patients in the sham acupuncture group will receive sham acupuncture 3 times a week for 4 weeks (12 sessions).
|
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:
|
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)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
- Andersen L, Hojris I, Erlandsen M, Andersen J. Treatment of breast-cancer-related lymphedema with or without manual lymphatic drainage--a randomized study. Acta Oncol. 2000;39(3):399-405. doi: 10.1080/028418600750013186.
- Zhu H, Li J, Peng Z, Huang Y, Lv X, Song L, Zhou G, Lin S, Chen J, He B, Qin F, Liu X, Dai M, Zou Y, Dai S. Effectiveness of acupuncture for breast cancer related lymphedema: protocol for a single-blind, sham-controlled, randomized, multicenter trial. BMC Complement Altern Med. 2017 Sep 21;17(1):467. doi: 10.1186/s12906-017-1980-0.
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
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