Warm Acupuncture for Breast Cancer Related Lymphedema

NCT03373474 | Completed DMC

• 1 other identifier: 2014CB543202-02
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Lymphedema

Outcome Measures

Primary Outcomes (1)

• Upper extremity circumference

  Various assessment methods are available but circumference measure is simple, convenient with low cost, and reliable. Therefore, the primary outcome measures will be the mean change in inter-limb circumference difference from baseline to the end of the 8-week intervention. The circumference will be measured by the measurement tape (Gulick Attachment, Baseline, America) at the wrist crease, 10 cm above the wrist crease, elbow crease, 10 cm above the elbow crease, where the lymphedema is most severe and its corresponding location on the unaffected limb.

  80 weeks

Secondary Outcomes (5)

• 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

Study Arms (3)

local distribution points association

EXPERIMENTAL

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

Other: local distribution points association

local-distal points association

EXPERIMENTAL

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

Other: local-distal points association

waiting-list

NO INTERVENTION

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.

Interventions

local distribution points association OTHER

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.

local distribution points association

local-distal points association OTHER

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.

local-distal points association

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin University of Traditional Chinese Medicine: lead
• National Basic Research Program, China: collaborator
• Tianjin Medical University Cancer Institute and Hospital: collaborator
• The Second Affiliated Hospital of Baotou Medical College: collaborator
• Henan Provincial People's Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• Sichuan Cancer Hospital and Research Institute: collaborator

Study Sites (1)

Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, China

Location

Related Publications (1)

• Yeh CH, Zhao TY, Zhao MD, Wu Y, Guo YM, Pan ZY, Dong RW, Chen B, Wang B, Wen JR, Li D, Guo Y, Pan XF. Comparison of effectiveness between warm acupuncture with local-distal points combination and local distribution points combination in breast cancer-related lymphedema patients: a study protocol for a multicenter, randomized, controlled clinical trial. Trials. 2019 Jul 5;20(1):403. doi: 10.1186/s13063-019-3491-4.

  PMID: 31277678 DERIVED

MeSH Terms

Conditions

Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• XingFang Pan

  Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Dean of Acupuncture and Moxibustion College

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 14, 2017
• Study Start: January 18, 2018
• Primary Completion: May 26, 2020
• Study Completion: December 26, 2020
• Last Updated: May 6, 2021

Record last verified: 2021-04

Locations

CN (1)