NCT02803736

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable breast-cancer

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 23, 2016

Status Verified

November 1, 2016

Enrollment Period

2.8 years

First QC Date

June 14, 2016

Last Update Submit

November 21, 2016

Conditions

Breast CancerLymphedemaAcupuncture

Outcome Measures

Primary Outcomes (1)

  • 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 Ă—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 Outcomes (1)

  • Incidence of Adverse Event

    Day 0 (baseline), Day 30(endpoint)

Study Arms (2)

Real acupuncture group

EXPERIMENTAL

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

Sham acupuncture group

SHAM COMPARATOR

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

Device: acupuncture

Interventions

acupunctureDEVICE

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.

Also known as: zhen jiu
Real acupuncture groupSham acupuncture group

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 10987238BACKGROUND

  • 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.

    PMID: 28934950DERIVED

MeSH Terms

Conditions

Breast NeoplasmsLymphedema

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Xiangcheng Wei

    Guangxi Medical University Institutional Review Board

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zheng Peng

CONTACT

+86 772 38401441371@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2016

First Posted

June 17, 2016

Study Start

December 1, 2016

Primary Completion

October 1, 2019

Study Completion

December 1, 2019

Last Updated

November 23, 2016

Record last verified: 2016-11