Effectiveness of Acupuncture in Post-Mastectomy Patients With Tissue Expanders

August 2, 2016 updated by: NYU Langone Health
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Withdrawn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

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 6 Weeks
6 Weeks
Chest Tightness Score on Pain and Discomfort Assessment Questionnaire
Time Frame: 6 Weeks
6 Weeks
General Pain Score on Pain and Discomfort Assessment Questionnaire
Time Frame: 6 Weeks
6 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Freya Schnabel, MD, New York University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • 12-03266

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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