Effectiveness of Acupuncture in Post-Mastectomy Patients With Tissue Expanders

Breast Cancer Clinical Trial

Official title:

Effectiveness of Acupuncture in Post-Mastectomy Patients With Tissue Expanders

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02639611
• Other study ID #: 12-03266
• Status: Withdrawn
• Phase: N/A
• First received: December 22, 2015
• Last updated: August 2, 2016
• Start date: July 2013

Study information

• Verified date: August 2016
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• Immediate Post Operative Acupuncture Treatment
acupuncture treatment immediately after surgery (twice a week for 6 weeks)
• No Acupuncture Treatment
no acupuncture treatment for 6 weeks, but offered acupuncture at the end of the 6 week study period.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder Tightness Score on Pain and Discomfort Assessment Questionnaire		6 Weeks	No
Primary	Chest Tightness Score on Pain and Discomfort Assessment Questionnaire		6 Weeks	No
Primary	General Pain Score on Pain and Discomfort Assessment Questionnaire		6 Weeks	No