Effectiveness of Acupuncture in Post-Mastectomy Patients With Tissue Expanders

NCT02639611 | Withdrawn DMC

• 1 other identifier: 12-03266
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Expanders

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Immediate Post Operative Acupuncture Treatment

ACTIVE COMPARATOR

Other: Immediate Post Operative Acupuncture Treatment

Acupuncture Treatment After 6 Weeks of Recovery

ACTIVE COMPARATOR

Other: No Acupuncture Treatment

Interventions

Immediate Post Operative Acupuncture Treatment OTHER

acupuncture treatment immediately after surgery (twice a week for 6 weeks)

Immediate Post Operative Acupuncture Treatment

No Acupuncture Treatment OTHER

no acupuncture treatment for 6 weeks, but offered acupuncture at the end of the 6 week study period.

Acupuncture Treatment After 6 Weeks of Recovery

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Freya Schnabel, MD

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: December 24, 2015
• Study Start: July 1, 2013
• Primary Completion: February 1, 2016
• Last Updated: August 3, 2016

Record last verified: 2016-08

Locations

US (1)