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Warm Acupuncture for Breast Cancer Related Lymphedema

Primary Purpose

Breast Cancer Lymphedema

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
local distribution points association
local-distal points association
Sponsored by
Tianjin University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Lymphedema

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

local distribution points association

local-distal points association

waiting-list

Arm Description

Participants will receive warm acupuncture with the local distribution acupoints association on the affected arm only.

Participants will receive warm acupuncture with the local-distal acupoints association on the affected arm, unaffected arm, abdomen, and legs.

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.

Outcomes

Primary Outcome Measures

Upper extremity circumference
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

Upper extremity 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 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
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.
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) 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)
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.

Full Information

First Posted
December 7, 2017
Last Updated
April 30, 2021
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 People's Hospital, Qilu Hospital of Shandong University, Sichuan Cancer Hospital and Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03373474
Brief Title
Warm Acupuncture for Breast Cancer Related Lymphedema
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 18, 2018 (Actual)
Primary Completion Date
May 26, 2020 (Actual)
Study Completion Date
December 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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 People's Hospital, Qilu Hospital of Shandong University, Sichuan Cancer Hospital and Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Lymphedema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
local distribution points association
Arm Type
Experimental
Arm Description
Participants will receive warm acupuncture with the local distribution acupoints association on the affected arm only.
Arm Title
local-distal points association
Arm Type
Experimental
Arm Description
Participants will receive warm acupuncture with the local-distal acupoints association on the affected arm, unaffected arm, abdomen, and legs.
Arm Title
waiting-list
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
local distribution points association
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
local-distal points association
Intervention Description
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.
Primary Outcome Measure Information:
Title
Upper extremity circumference
Description
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.
Time Frame
80 weeks
Secondary Outcome Measure Information:
Title
Upper extremity volume
Description
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.
Time Frame
80 weeks
Title
Common terminology criteria for adverse events (CTCAE 4.03) - edema limbs criteria
Description
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.
Time Frame
80 weeks
Title
Stages of lymphedema from the international society of lymphology
Description
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.
Time Frame
80 weeks
Title
The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure
Description
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.
Time Frame
80 weeks
Title
The MOS 36-Item Short-Form Health Survey (SF-36)
Description
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.
Time Frame
80 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XingFang Pan
Organizational Affiliation
Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine
City
Tianjin
State/Province
Tianjin
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
31277678
Citation
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.
Results Reference
derived

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Warm Acupuncture for Breast Cancer Related Lymphedema

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