Effectiveness of Acupuncture in Post-Mastectomy Patients With Tissue Expanders

Not Applicable

Withdrawn

• Conditions: Breast Cancer
• Interventions: Other: No Acupuncture Treatment; Other: Immediate Post Operative Acupuncture Treatment

• Registration Number: NCT02639611
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2015-12-22
• Study First Submitted QC: 2015-12-22
• Study First Posted: 2015-12-24
• Primary Completion: 2016-02
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-02
• Last Update Posted: 2016-08-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture Treatment After 6 Weeks of Recovery	No Acupuncture Treatment	-
Immediate Post Operative Acupuncture Treatment	Immediate Post Operative Acupuncture Treatment	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States