Warm Acupuncture for Breast Cancer Related Lymphedema

• ClinicalTrials.gov Identifier: NCT03373474
• Recruitment Status: Recruiting
• First Posted: December 14, 2017
• Last Update Posted: December 18, 2018
• Sponsor: Tianjin University of Traditional Chinese Medicine
• Collaborators: National Basic Research Program, China; Tianjin Medical University Cancer Institute and Hospital; The Second Affiliated Hospital of Baotou Medical College; Henan Provincial Cancer Hospital; Qilu Hospital of Shandong University; Sichuan Cancer Hospital and Research Institute
• Information provided by (Responsible Party): Yi Guo, Tianjin University of Traditional Chinese Medicine

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer Lymphedema	Other: local distribution points association; Other: local-distal points association	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: January 20, 2018
• Estimated Primary Completion Date: March 2019
• Estimated Study Completion Date: May 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: local distribution points association; Participants will receive warm acupuncture with the local distribution acupoints association on the affected arm only.	Other: local distribution points association; Participants will receive acupuncture treatments using the local points set plus the local-addition points set (local distribution association) described below. Warming acupuncture will be applied at HT2, LI11, and TE9 if permitted. Local points set: TE5, LI11, TE9, HT3, TE13, and Xiajiquan on the affected arm. Local-addition points set: LU5, PC3, SI7, TE4, TE3, HT2, TE10, LI15, and 2 other points according to the symptom on the affected arm.
Experimental: local-distal points association; Participants will receive warm acupuncture with the local-distal acupoints association on the affected arm, unaffected arm, abdomen, and legs.	Other: local-distal points association; Participants will receive acupuncture treatments using the local points set plus the distal points set (local-distal association) described below. Warming acupuncture will be applied similarly to the local distribution group, with the addition of Ren6, Ren9, bilateral SP9, and LI11 on the unaffected arm. Local points set: TE5, LI11, TE9, HT3, TE13, and Xiajiquan on the affected arm. Distal points set: TE5, LI11, HT3, TE13 on the unaffected arm; CV4, CV6, CV9, CV12, bilateral SP6 and SP9.
No Intervention: waiting-list; 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.

Outcome Measures

Primary Outcome Measures :

1. Upper extremity circumference [ Time Frame: 8 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 :

1. Upper extremity volume [ Time Frame: 8 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.
2. Skin hardness [ Time Frame: 8 weeks ]
   Skin hardness will be measured at places where the skin feels most tense to the touch by the NEUTONE TDM-NA1 (DX) muscle hardness tester (Try-All Corporation, Chiba City, Japan). The location of the measurement will be recorded and the corresponding location on the unaffected limb will also be measured to obtain inter-limb difference in skin hardness.
3. Common terminology criteria for adverse events (CTCAE 4.03) - edema limbs criteria [ Time Frame: 8 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.
4. Stages of lymphedema from the international society of lymphology [ Time Frame: 8 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.
5. The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure [ Time Frame: 8 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.
6. The MOS 36-Item Short-Form Health Survey (SF-36) [ Time Frame: 8 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: XingFang Pan; 18649067519; panxingfang@163.com

Locations

China, Tianjin

Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine; Recruiting

Tianjin, Tianjin, China

Contact: XingFang Pan 18649067519 panxingfang@163.com

Sponsors and Collaborators

Tianjin University of Traditional Chinese Medicine

National Basic Research Program, China

Tianjin Medical University Cancer Institute and Hospital

The Second Affiliated Hospital of Baotou Medical College

Henan Provincial Cancer Hospital

Qilu Hospital of Shandong University

Sichuan Cancer Hospital and Research Institute

Investigators

• Principal Investigator: XingFang Pan; Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Yi Guo, The Dean of Acupuncture and Moxibustion College, Tianjin University of Traditional Chinese Medicine
• ClinicalTrials.gov Identifier: NCT03373474 History of Changes
• Other Study ID Numbers: 2014CB543202-02
• First Posted: December 14, 2017
• Last Update Posted: December 18, 2018
• Last Verified: December 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Lymphatic Diseases; Postoperative Complications; Pathologic Processes