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
About this trial
This is an interventional treatment trial for Breast Cancer
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.
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
NCT ID
NCT02803736
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
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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