Effectiveness of Acupuncture for Breast Cancer Related Lymphedema
NCT ID: NCT02803736
Last Updated: 2016-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2016-12-31
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
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.
Sham acupuncture group
Patients in the sham acupuncture group will receive sham acupuncture 3 times a week for 4 weeks (12 sessions).
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
45 Years
FEMALE
No
Sponsors
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Liuzhou Hospital of Traditional Chinese Medicine
OTHER
Liuzhou Maternity and Child Healthcare Hospital
OTHER
Fourth Affiliated Hospital of Guangxi Medical University
OTHER
Responsible Party
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Principal Investigators
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Xiangcheng Wei
Role: PRINCIPAL_INVESTIGATOR
Guangxi Medical University Institutional Review Board
Central Contacts
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References
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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.
Other Identifiers
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PJK201690
Identifier Type: -
Identifier Source: org_study_id