Warm Acupuncture for Breast Cancer Related Lymphedema
- Conditions
- Breast Cancer Lymphedema
- Interventions
- Other: local distribution points associationOther: local-distal points association
- Registration Number
- NCT03373474
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description local distribution points association local distribution points association Participants will receive warm acupuncture with the local distribution acupoints association on the affected arm only. local-distal points association local-distal points association Participants will receive warm acupuncture with the local-distal acupoints association on the affected arm, unaffected arm, abdomen, and legs.
- Primary Outcome Measures
Name Time Method Upper extremity circumference 80 weeks 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.
- Secondary Outcome Measures
Name Time Method Upper extremity volume 80 weeks 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 8-week intervention will be included as the second 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.
Common terminology criteria for adverse events (CTCAE 4.03) - edema limbs criteria 80 weeks Common terminology criteria for adverse events (CTCAE 4.03) will be used to grade the severity of swelling using the edema limbs criteria. A grading of mild, moderate or severe swelling will be assessed based on the inter-limb circumference or volume discrepancy, anatomic architecture, appearance, or activities of daily living. The CTCAE 4.03 will allow us to evaluate the clinical significance of circumference change.
Stages of lymphedema from the international society of lymphology 80 weeks Stages of lymphedema from the international society of lymphology will be used to grade the severity of lymphedema. Staging of 0, I, II, or III will be assessed based on severity of swelling, ability to reduce swelling by elevation, and skin changes.
The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure 80 weeks Disabilities of the arm, shoulder, and hand (DASH) is a scale consists of two concepts: functional status (part A) and symptoms (part B) respectively. The functional status part is further divided into three dimensions: physical, social, and psychological. The total score of the DASH ranges from 0 to 100 with higher scores representing worse symptoms and function. The DASH has good validity and responsiveness and it is recommended to assess upper extremity function in breast cancer survivors. The validated Chinese version of the DASH will be used in this study.
The MOS 36-Item Short-Form Health Survey (SF-36) 80 weeks The medical outcome study 36-item short-form health survey (SF-36) is a commonly used instrument to assess quality of life that has good validity. The SF-36 includes the following eight concepts: physical functioning, role limitations due to physical problems, social functioning, bodily pain, general mental health, role limitations due to emotional problems, vitality, and general health perception. The validated Chinese version of the SF-36 will be used in this study.
Trial Locations
- Locations (1)
Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine
🇨🇳Tianjin, Tianjin, China