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Effectiveness of Acupuncture in Post-Mastectomy Patients With Tissue Expanders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02639611
Recruitment Status : Withdrawn
First Posted : December 24, 2015
Last Update Posted : August 3, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: Immediate Post Operative Acupuncture Treatment Other: No Acupuncture Treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Acupuncture in Post-Mastectomy Patients With Tissue Expanders
Study Start Date : July 2013
Actual Primary Completion Date : February 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Shoulder Tightness Score on Pain and Discomfort Assessment Questionnaire [ Time Frame: 6 Weeks ]
  2. Chest Tightness Score on Pain and Discomfort Assessment Questionnaire [ Time Frame: 6 Weeks ]
  3. General Pain Score on Pain and Discomfort Assessment Questionnaire [ Time Frame: 6 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639611


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Freya Schnabel, MD New York University Medical School
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02639611    
Other Study ID Numbers: 12-03266
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: August 2016
Keywords provided by NYU Langone Health:
Breast Expanders