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Warm Acupuncture for Breast Cancer Related Lymphedema

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ClinicalTrials.gov Identifier: NCT03373474
Recruitment Status : Recruiting
First Posted : December 14, 2017
Last Update Posted : December 18, 2018
Sponsor:
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

Tracking Information
First Submitted Date  ICMJE December 7, 2017
First Posted Date  ICMJE December 14, 2017
Last Update Posted Date December 18, 2018
Actual Study Start Date  ICMJE January 20, 2018
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 13, 2017)
  • Upper extremity circumference [ Time Frame: 8 weeks ]
  • Upper extremity volume [ Time Frame: 8 weeks ]
Change History Complete list of historical versions of study NCT03373474 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2017)
  • 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.
  • Common terminology criteria for adverse events (CTCAE 4.03) - edema limbs criteria [ Time Frame: 8 weeks ]
  • Staging of lymphedema from the international society of lymphology [ Time Frame: 8 weeks ]
  • The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure [ Time Frame: 8 weeks ]
  • The MOS 36-Item Short-Form Health Survey (SF-36) [ Time Frame: 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Warm Acupuncture for Breast Cancer Related Lymphedema
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer Lymphedema
Intervention  ICMJE
  • 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.

  • 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.

Study Arms  ICMJE
  • Experimental: local distribution points association
    Participants will receive warm acupuncture with the local distribution acupoints association on the affected arm only.
    Intervention: Other: local distribution points association
  • 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.
    Intervention: Other: local-distal points association
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 13, 2017)
108
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: XingFang Pan 18649067519 panxingfang@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03373474
Other Study ID Numbers  ICMJE 2014CB543202-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yi Guo, Tianjin University of Traditional Chinese Medicine
Study Sponsor  ICMJE Tianjin University of Traditional Chinese Medicine
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: XingFang Pan Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine
PRS Account Tianjin University of Traditional Chinese Medicine
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP