Acupuncture for Breast Cancer Related Lymphedema

Effectiveness of Acupuncture for Breast Cancer Related Lymphedema Patients: a Multicenter, Randomized, Sham-controlled Clinical Trial

The purpose of this study is to evaluate the clinical efficacy of acupuncture on chronic upper limb lymphedema in patients with breast cancer surgery

Study Overview

• Status: Unknown
• Conditions: Breast Cancer Lymphedema
• Intervention / Treatment: Other: acupuncture; Other: sham acupuncture

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pan XingFang; Phone Number: 18649067519; Email: panxingfang@163.com
• Study Contact Backup: Name: Pan XingFang, Study Principal Investigator; Phone Number: 18649067519; Email: panxingfang@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.
• 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

Exclusion Criteria:

• 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
• Participation in other clinical trials during the study period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture group; Subjects in the acupuncture group are given acupuncture treatment.	Other: acupuncture; 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.
Experimental: Sham acupuncture control group; Subjects in the sham acupuncture control group are given non-acupoint shallow acupuncture.	Other: sham acupuncture; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper extremities circumferences	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 7-week intervention. The circumference will be measured by the measurement tape (Gulick Attachment, Baseline, America) at the wrist crease,5 cm above the wrist crease,10 cm above the wrist crease,15 cm above the wrist crease,20 cm above the wrist crease,25 cm above the wrist crease,30 cm above the wrist crease,35 cm above the wrist crease,where the lymphedema is most severe and its corresponding location on the unaffected limb.	7 weeks
VAS distension score	The VAS distension score is used to assess the degree of self-distension feeling at the affected upper extremities. It is evaluated by drawing a 10 cm horizontal line on the paper. One end of the horizontal line is 0, indicating no distension feeling; the other end is 10, indicating that the distension is unbearable; the middle part indicates different degrees of swelling. Let the subject draw a mark on the horizontal line according to the feeling of self-indicating degree of distension.	7 weeks
Common terminology criteria for adverse events (CTCAE 4.03) - edema limbs criteria	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 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.	7 weeks
The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure	Disabilities of the arm, shoulder, and hand (DASH) is a scale consists of two concepts: functional status (part A) andsymptoms (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.	7 weeks
The MOS 36-Item Short-Form Health Survey (SF-36)	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.	7 weeks

Collaborators and Investigators

• Sponsor: Tianjin University of Traditional Chinese Medicine
• Collaborators: Tianjin Medical University Cancer Institute and Hospital; Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine; Gansu Provincial Cancer Hospital; The Second Affiliated Hospital of Baotou Medical College

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2019
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: November 6, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (Actual): November 8, 2019

Study Record Updates

• Last Update Posted (Actual): November 8, 2019
• Last Update Submitted That Met QC Criteria: November 6, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Postoperative Complications; Breast Diseases; Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema
• Other Study ID Numbers: 2014CB543202-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No