Back to resultsAcupuncture for Breast Cancer Related Lymphedema
Primary Purpose
Breast Cancer Lymphedema
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
acupuncture
sham acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer Lymphedema
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.
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Acupuncture group
Sham acupuncture control group
Arm Description
Subjects in the acupuncture group are given acupuncture treatment.
Subjects in the sham acupuncture control group are given non-acupoint shallow acupuncture.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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) 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.
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
NCT ID
NCT04158193
First Posted
November 6, 2019
Last Updated
November 6, 2019
Sponsor
Tianjin University of Traditional Chinese Medicine
Collaborators
Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine, Tianjin Medical University Cancer Institute and Hospital, Gansu Provincial Cancer Hospital, The Second Affiliated Hospital of Baotou Medical College
1. Study Identification
Unique Protocol Identification Number
NCT04158193
Brief Title
Acupuncture for Breast Cancer Related Lymphedema
Official Title
Effectiveness of Acupuncture for Breast Cancer Related Lymphedema Patients: a Multicenter, Randomized, Sham-controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2019 (Anticipated)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
April 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin University of Traditional Chinese Medicine
Collaborators
Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine, Tianjin Medical University Cancer Institute and Hospital, Gansu Provincial Cancer Hospital, The Second Affiliated Hospital of Baotou Medical College
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 evaluate the clinical efficacy of acupuncture on chronic upper limb lymphedema in patients with breast cancer surgery
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
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture group
Arm Type
Experimental
Arm Description
Subjects in the acupuncture group are given acupuncture treatment.
Arm Title
Sham acupuncture control group
Arm Type
Experimental
Arm Description
Subjects in the sham acupuncture control group are given non-acupoint shallow acupuncture.
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
sham acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Upper extremities 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 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.
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Upper extremities circumferences
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 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.
Time Frame
7 weeks
Title
VAS distension score
Description
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.
Time Frame
7 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. 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.
Time Frame
7 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) 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.
Time Frame
7 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
7 weeks
10. Eligibility
Sex
Female
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.
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pan XingFang
Phone
18649067519
Email
panxingfang@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pan XingFang, Study Principal Investigator
Phone
18649067519
Email
panxingfang@163.com
12. IPD Sharing Statement
Learn more about this trial
Acupuncture for Breast Cancer Related Lymphedema
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