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Warm Acupuncture for Breast Cancer Related Lymphedema

T

Tianjin University of Traditional Chinese Medicine

Status

Completed

Conditions

Breast Cancer Lymphedema

Treatments

Other: local distribution points association
Other: local-distal points association

Study type

Interventional

Funder types

Other

Identifiers

NCT03373474
2014CB543202-02

Details and patient eligibility

About

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.

Enrollment

108 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

108 participants in 3 patient groups

local distribution points association
Experimental group
Description:
Participants will receive warm acupuncture with the local distribution acupoints association on the affected arm only.
Treatment:
Other: local distribution points association
local-distal points association
Experimental group
Description:
Participants will receive warm acupuncture with the local-distal acupoints association on the affected arm, unaffected arm, abdomen, and legs.
Treatment:
Other: local-distal points association
waiting-list
No Intervention group
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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