Effectiveness of Acupuncture in Post-Mastectomy Patients With Tissue Expanders

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.

Study Overview

• Status: Withdrawn
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Immediate Post Operative Acupuncture Treatment; Other: No Acupuncture Treatment

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Freya Schnabel, MD, New York University Medical School

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ACTUAL): February 1, 2016

Study Registration Dates

• First Submitted: December 22, 2015
• First Submitted That Met QC Criteria: December 22, 2015
• First Posted (ESTIMATE): December 24, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): August 3, 2016
• Last Update Submitted That Met QC Criteria: August 2, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Breast Expanders
• Other Study ID Numbers: 12-03266