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Effectiveness of Acupuncture for Breast Cancer Related Lymphedema (Acupuncture)

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ClinicalTrials.gov Identifier: NCT02803736
Recruitment Status : Not yet recruiting
First Posted : June 17, 2016
Last Update Posted : November 23, 2016
Sponsor:
Collaborators:
Liuzhou Hospital of Traditional Chinese Medicine
Liuzhou Maternity and Child Healthcare Hospital
Information provided by (Responsible Party):
Fourth Affiliated Hospital of Guangxi Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Lymphedema Acupuncture Device: acupuncture Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effectiveness of Acupuncture for Breast Cancer Related Lymphedema
Study Start Date : December 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: zhen jiu




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02803736


Contacts
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Contact: Zheng Peng +86 772 3840144 1371@sina.com

Sponsors and Collaborators
Fourth Affiliated Hospital of Guangxi Medical University
Liuzhou Hospital of Traditional Chinese Medicine
Liuzhou Maternity and Child Healthcare Hospital
Investigators
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Principal Investigator: Xiangcheng Wei Guangxi Medical University Institutional Review Board

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fourth Affiliated Hospital of Guangxi Medical University
ClinicalTrials.gov Identifier: NCT02803736     History of Changes
Other Study ID Numbers: PJK201690
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Breast Neoplasms
Lymphedema
Breast Cancer Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases
Postoperative Complications
Pathologic Processes