Exercise in Breast Cancer Survivors

NCT ID: NCT01582685

Last Updated: 2014-12-02

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WITHDRAWN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

2012-04-30

Study Completion Date

2014-06-30

Brief Summary

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The investigators hypothesize that exercise in postmenopausal breast cancer survivors will result in an increase in the plasma concentrations of angiostatic factors and a decrease in the plasma concentrations of angiogenic factors. Exercise is expected to result in a circulating angiostatic phenotype that inhibits adipose tissue mass, growth of breast cancer tumor, growth of microscopic residual disease after breast cancer resection, decreases rates of local-regional recurrence, decreases rates of distant recurrence, and increases survival.

Detailed Description

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Conditions

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Breast Cancer Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Exercise Group

The intervention is a structured walking program which will be performed partly in the Pavilion Physical Therapy clinic and partly at home. The participant will be instructed in how hard to exercise, how long to exercise, and how many times in a week to exercise. You will also be instructed in how to exercise safely.

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

The participant will exercise for 16 weeks under supervision. The exercise regimen is increased slowly over 16 weeks.

No Exercise

These participants will receive standard of care follow up.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

The participant will exercise for 16 weeks under supervision. The exercise regimen is increased slowly over 16 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* \> 18 years of age and \< 65 years of age
* Female
* BMI \> 25
* Weight \< 350 pounds
* English as a primary language
* Postmenopausal
* Invasive ER-positive cancer on biopsy and subsequent definitive surgical therapy
* Received and Completed standard of care adjuvant therapy (Concurrent endocrine therapy acceptable)
* 6-12 months after completion of therapy (excluding adjuvant endocrine therapy) at time of randomization

Exclusion Criteria

* Recurrent breast cancer
* DCIS only (no invasive component)
* Taking a Beta Blocker or Verapamil
* Pregnant
* Wheelchair bound
* Unable to ambulate independently
* Concurrent uncontrolled medical or psychiatric disorder
* Open wound
* Stage IV breast cancer
* Progression of disease
* Bilateral mastectomies
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Mississippi Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Natale Sheehan

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Natale Sheehan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Health Care

Locations

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University of Mississippi Health Care

Jackson, Mississippi, United States

Site Status

Countries

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United States

Other Identifiers

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2011-0121

Identifier Type: -

Identifier Source: org_study_id