Effectiveness of Acupuncture in Post-Mastectomy Patients With Tissue Expanders

Study Overview
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Brief Summary
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The primary purpose of this study is to evaluate changes in shoulder tightness, chest tightness, and general pain related to post-mastectomy reconstructive surgery with tissue expansion in women who are randomized to receive acupuncture treatment immediately after surgery (twice a week for 6 weeks) compared to those who are randomized to no acupuncture treatment for 6 weeks, but offered acupuncture at the end of the 6 week study period.

Official Title
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Effectiveness of Acupuncture in Post-Mastectomy Patients With Tissue Expanders

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Immediate Post Operative Acupuncture Treatment
* Other: No Acupuncture Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who are newly diagnosed with breast cancer, enrolled in the The Breast Cancer Database of NYU Cancer Center (BCD) and who are having breast cancer surgery involving a mastectomy procedure with insertion of a tissue expander for reconstructive purposes Women who are newly diagnosed with breast cancer Women who are enrolled in the Breast Cancer Database (BCD) Women who are having breast cancer surgery involving a mastectomy procedure with insertion of a tissue expander for reconstructive purposes Exclusion Criteria: Women who had neoadjuvant chemotherapy and/or radiation therapy, women who are currently on anticoagulant therapy, women who are having breast reconstruction with Alloderm, women who have chronic pre-operative pain, and/or women who have had a history of previous implants or prior augmentations Women who had neoadjuvant chemotherapy and/or radiation therapy Women who are currently on anticoagulant therapy Women who are having breast reconstruction with Alloderm Women who have chronic pre-operative pain Women who have had a history of previous implants or prior augmentations Women who are currently on anticoagulant therapy Women who are having breast reconstruction with Alloderm Women who have chronic pre-operative pain Women who have had a history of previous implants or prior augmentations

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immediate Post Operative Acupuncture Treatment<br> | Other: Immediate Post Operative Acupuncture Treatment<br>* acupuncture treatment immediately after surgery (twice a week for 6 weeks)<br>|
| Active Comparator: Acupuncture Treatment After 6 Weeks of Recovery<br> | Other: No Acupuncture Treatment<br>* no acupuncture treatment for 6 weeks, but offered acupuncture at the end of the 6 week study period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder Tightness Score on Pain and Discomfort Assessment Questionnaire |  | 6 Weeks | 
| Chest Tightness Score on Pain and Discomfort Assessment Questionnaire |  | 6 Weeks | 
| General Pain Score on Pain and Discomfort Assessment Questionnaire |  | 6 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Expanders