Warm Acupuncture for Breast Cancer Related Lymphedema

Comparison of Effectiveness Between Warm Acupuncture With Local-Distal Points Association and Local Distribution Points Association in Breast Cancer Related Lymphedema Patients: A Multicenter, Randomized, Controlled Clinical Trial

Sponsors

Lead Sponsor: Tianjin University of Traditional Chinese Medicine

Collaborator: National Basic Research Program, China
Tianjin Medical University Cancer Institute and Hospital
The Second Affiliated Hospital of Baotou Medical College
Henan Provincial Cancer Hospital
Qilu Hospital of Shandong University
Sichuan Cancer Hospital and Research Institute

Source Tianjin University of Traditional Chinese Medicine
Brief Summary

The purpose of this study is to clarify whether local-distal point association is more effective than local point association by warm acupuncture in the management of breast cancer related lymphedema.

Overall Status Completed
Start Date 2018-01-18
Completion Date 2020-12-26
Primary Completion Date 2020-05-26
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Upper extremity circumference 80 weeks
Secondary Outcome
Measure Time Frame
Upper extremity volume 80 weeks
Common terminology criteria for adverse events (CTCAE 4.03) - edema limbs criteria 80 weeks
Stages of lymphedema from the international society of lymphology 80 weeks
The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure 80 weeks
The MOS 36-Item Short-Form Health Survey (SF-36) 80 weeks
Enrollment 108
Condition
Intervention

Intervention Type: Other

Intervention Name: local distribution points association

Description: Participants will receive acupuncture treatments using the local points set plus the local-addition points set (local distribution association) described below. Warming acupuncture will be applied at HT2, LI11, and TE9 if permitted. Local points set: TE5, LI11, TE9, HT3, TE13, and Xiajiquan on the affected arm. Local-addition points set: LU5, PC3, SI7, TE4, TE3, HT2, TE10, LI15, and 2 other points according to the symptom on the affected arm.

Arm Group Label: local distribution points association

Intervention Type: Other

Intervention Name: local-distal points association

Description: Participants will receive acupuncture treatments using the local points set plus the distal points set (local-distal association) described below. Warming acupuncture will be applied similarly to the local distribution group, with the addition of Ren6, Ren9, bilateral SP9, and LI11 on the unaffected arm. Local points set: TE5, LI11, TE9, HT3, TE13, and Xiajiquan on the affected arm. Distal points set: TE5, LI11, HT3, TE13 on the unaffected arm; CV4, CV6, CV9, CV12, bilateral SP6 and SP9.

Arm Group Label: local-distal points association

Eligibility

Criteria:

Inclusion Criteria: - At least 6 months after breast cancer surgery and presents with persistent breast cancer related upper extremity lymphedema for at least 3 months. Upper extremity lymphedema is defined as more than 2cm circumference difference or 5% volume difference between the affected and unaffected arms. - Stage II or III lymphedema according to the 2016 consensus by the international society of lymphology. - Karnofsky Performance Score (KPS) ≥ 70 - Men or women aged 18 to 80 years - Out-patients - Estimated life expectancy > 6 months Exclusion Criteria: - Bilateral breast cancer related lymphedema - Taking diuretic - History of primary lymphedema - A diagnosis of severe heart, liver, kidney or hematologic disease - Edema caused by upper extremity disability or other conditions such as heart failure, kidney disease or malnutrition - Have hypoproteinemia - Inflammation, scar, or trauma at the site of operation, or other active skin infections - Unable to self-care, had a history of psychological disorders, or unable to communicate - Received lymphedema treatment within the past 1 month - Pregnancy or breastfeeding - The presence of electronic medical device implants - Deny to sign the informed written consent, or unwilling to conform to randomization - Participation in other clinical trials during the study period

Gender:

All

Minimum Age:

18 Years

Maximum Age:

80 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
XingFang Pan Principal Investigator Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine
Overall Contact

Last Name: XingFang Pan

Phone: 18649067519

Email: [email protected]

Location
Facility: Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine
Location Countries

China

Verification Date

2021-04-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Tianjin University of Traditional Chinese Medicine

Investigator Full Name: Yi Guo

Investigator Title: The Dean of Acupuncture and Moxibustion College

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: local distribution points association

Type: Experimental

Description: Participants will receive warm acupuncture with the local distribution acupoints association on the affected arm only.

Label: local-distal points association

Type: Experimental

Description: Participants will receive warm acupuncture with the local-distal acupoints association on the affected arm, unaffected arm, abdomen, and legs.

Label: waiting-list

Type: No Intervention

Description: Patients in the waiting-list group will not receive any acupuncture treatment during the study. However, for ethical consideration, 20 free acupuncture treatments will be offered after the study is completed.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

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