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Effectiveness of Acupuncture for Breast Cancer Related Lymphedema (Acupuncture)

Primary Purpose

Breast Cancer, Lymphedema, Acupuncture

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
acupuncture
Sponsored by
Fourth Affiliated Hospital of Guangxi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Real acupuncture group

    Sham acupuncture group

    Arm Description

    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.

    Patients in the sham acupuncture group will receive sham acupuncture 3 times a week for 4 weeks (12 sessions).

    Outcomes

    Primary Outcome Measures

    Absolute Reduced Limb Volume Ratio
    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

    Incidence of Adverse Event
    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.

    Full Information

    First Posted
    June 14, 2016
    Last Updated
    November 21, 2016
    Sponsor
    Fourth Affiliated Hospital of Guangxi Medical University
    Collaborators
    Liuzhou Hospital of Traditional Chinese Medicine, Liuzhou Maternity and Child Healthcare Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02803736
    Brief Title
    Effectiveness of Acupuncture for Breast Cancer Related Lymphedema
    Acronym
    Acupuncture
    Official Title
    Effectiveness of Acupuncture for Breast Cancer Related Lymphedema
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2016 (undefined)
    Primary Completion Date
    October 2019 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fourth Affiliated Hospital of Guangxi Medical University
    Collaborators
    Liuzhou Hospital of Traditional Chinese Medicine, Liuzhou Maternity and Child Healthcare Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer, Lymphedema, Acupuncture

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Real acupuncture group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Sham acupuncture group
    Arm Type
    Sham Comparator
    Arm Description
    Patients in the sham acupuncture group will receive sham acupuncture 3 times a week for 4 weeks (12 sessions).
    Intervention Type
    Device
    Intervention Name(s)
    acupuncture
    Other Intervention Name(s)
    zhen jiu
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Absolute Reduced Limb Volume Ratio
    Description
    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.
    Time Frame
    Day 0 (baseline), Day 30(endpoint)
    Secondary Outcome Measure Information:
    Title
    Incidence of Adverse Event
    Description
    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.
    Time Frame
    Day 0 (baseline), Day 30(endpoint)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zheng Peng
    Phone
    +86 772 3840144
    Email
    1371@sina.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xiangcheng Wei
    Organizational Affiliation
    Guangxi Medical University Institutional Review Board
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    10987238
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28934950
    Citation
    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.
    Results Reference
    derived

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    Effectiveness of Acupuncture for Breast Cancer Related Lymphedema

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