Acupuncture for Breast Cancer Related Lymphedema
Effectiveness of Acupuncture for Breast Cancer Related Lymphedema Patients: a Multicenter, Randomized, Sham-controlled Clinical Trial
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the clinical efficacy of acupuncture on chronic upper limb lymphedema in patients with breast cancer surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2019
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
Study Start
First participant enrolled
November 1, 2019
CompletedFirst Submitted
Initial submission to the registry
November 6, 2019
CompletedFirst Posted
Study publicly available on registry
November 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedNovember 8, 2019
November 1, 2019
1 year
November 6, 2019
November 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Upper extremities volume
Volume measurement is also commonly used for the evaluation of lymphedema and the mean change in inter-limb volume difference from baseline to the end of the 7-week intervention will be included as primary outcome measure. The volume of the affected and unaffected limb will be measured by the volumetric measuring device (Baseline, America) using the water displacement method, which is considered as the most reliable method for volume measurements.
7 weeks
Secondary Outcomes (5)
Upper extremities circumferences
7 weeks
VAS distension score
7 weeks
Common terminology criteria for adverse events (CTCAE 4.03) - edema limbs criteria
7 weeks
The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure
7 weeks
The MOS 36-Item Short-Form Health Survey (SF-36)
7 weeks
Study Arms (2)
Acupuncture group
EXPERIMENTALSubjects in the acupuncture group are given acupuncture treatment.
Sham acupuncture control group
EXPERIMENTALSubjects in the sham acupuncture control group are given non-acupoint shallow acupuncture.
Interventions
Subjects in acupuncture group will be received acupuncture treatment by inserting LI11, SJ5, SJ9, SJ13, SJ10, HT3, PC2, LI4, and LI15 on the affected limb and RN12, RN9, RN6, RN4, SP9, SP6. Needles will be remained for 30 minutes each time after DeQi sensation, one time a day，three times a week, the treatment will be lasted for 7 weeks.
Subjects in control group will be treated with non-acupoint shallow needling, points will be selected 1 cm at the radial direction from acupoint LI11, SJ5, SJ9, SJ13, SJ10, LI4, HT3, PC2, LI4, LI15; 2 cm at the left of acupoint RN12, RN9, RN6, RN4; 1 cm at the tibial direction from SP9, SP6. The needling manipulation is the same as that of the acupuncture group, but only the superficial skin of points are punctured. The depth of needling is less than 0.5 cm, and no manipulation will be performed after puncturing the skin. Needles will be remained for 30 minutes each time,one time a day，three times a week, the treatment will be lasted for 7 weeks.
Eligibility Criteria
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.
- Stage II lymphedema according to the 2016 consensus by the international society of lymphology.
- Women aged 18 to 80 years
- Out-patients
- Estimated life expectancy \> 6 months
- Upper extremity lymphedema is defined a more than 10% volume difference between the affected and unaffected arms
You may not qualify if:
- Bilateral breast cancer related lymphedema
- Tumor metastasis or recurrent patient
- Patients who is undergoing chemotherapy, radiation therapy or targeted therapy
- Taking diuretic
- Upper extremity lymphedema reached more than 80% volume difference between the affected and unaffected arms
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tianjin University of Traditional Chinese Medicinelead
- Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicinecollaborator
- Tianjin Medical University Cancer Institute and Hospitalcollaborator
- Gansu Provincial Cancer Hospitalcollaborator
- The Second Affiliated Hospital of Baotou Medical Collegecollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
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 Traditional Chinese medicine College
Study Record Dates
First Submitted
November 6, 2019
First Posted
November 8, 2019
Study Start
November 1, 2019
Primary Completion
November 1, 2020
Study Completion
April 1, 2021
Last Updated
November 8, 2019
Record last verified: 2019-11