Effectiveness of Acupuncture in Post-Mastectomy Patients With Tissue Expanders

NCT ID: NCT02639611

Last Updated: 2016-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immediate Post Operative Acupuncture Treatment

Group Type ACTIVE_COMPARATOR

Immediate Post Operative Acupuncture Treatment

Intervention Type OTHER

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

Acupuncture Treatment After 6 Weeks of Recovery

Group Type ACTIVE_COMPARATOR

No Acupuncture Treatment

Intervention Type OTHER

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

Interventions

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Immediate Post Operative Acupuncture Treatment

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

Intervention Type OTHER

No Acupuncture Treatment

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Freya Schnabel, MD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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12-03266

Identifier Type: -

Identifier Source: org_study_id

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