Clinical trial NCT03373474: Warm Acupuncture for Breast Cancer Related Lymphedema
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Lymphedema
Lead sponsor: Tianjin University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: National Basic Research Program, China
name: Tianjin Medical University Cancer Institute and Hospital
name: The Second Affiliated Hospital of Baotou Medical College
name: Henan Provincial People's Hospital
name: Qilu Hospital of Shandong University
name: Sichuan Cancer Hospital and Research Institute
First posted: 2017-12-14
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Upper extremity circumference
timeFrame: 80 weeks
Secondary outcomes:
measure: Upper extremity volume
timeFrame: 80 weeks
measure: Common terminology criteria for adverse events (CTCAE 4.03) - edema limbs criteria
timeFrame: 80 weeks
measure: Stages of lymphedema from the international society of lymphology
timeFrame: 80 weeks
measure: The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure
timeFrame: 80 weeks
measure: The MOS 36-Item Short-Form Health Survey (SF-36)
timeFrame: 80 weeks
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine
state: Tianjin
Study officials:
affiliation: Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine
name: XingFang Pan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.