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WithdrawnNCT01582685Updated Dec 2, 2014

Exercise in Breast Cancer Survivors

An interventional study of Exercise in Breast Cancer and Obesity, sponsored by University of Mississippi Medical Center. Withdrawn at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-02.

Sponsored by University of Mississippi Medical Center · Not applicable, Interventional, and Prevention

Why this study was withdrawn
no patients enrolled
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study summary

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.

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Conditions studied

  • Breast Cancer
  • Obesity

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Keywords

  • Breast Cancer
  • Obesity
  • Exercise
  • Angiogenesis
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

Browse Breast Neoplasms studies →

Lead sponsor

University of Mississippi Medical Center is the lead sponsor of 125 studies on the registry; 19 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Exercise

  • No intervention
    No Exercise

    These participants will receive standard of care follow up.

Interventions

  • BehavioralExercise

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

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What researchers measure

Primary outcomes

  1. Number of participants that complete the study as a measure of feasibility of an exercise intervention in obese breast cancer survivors.

    Number of participants that enroll in the study and actually complete the study

    Time frame: 12 months

Secondary outcomes

  1. IGF-1, endostatin, and VEGF levels in obese breast cancer survivors undergoing an exercise intervention as a measure of angiostatic phenotype:

    IFG-1 levels,unbound VEGF levels, Endostatin levels

    Time frame: 12 months

  2. Amount of adipose tissue mass as measured on CT scans in obese breast cancer survivors before and after exercise intervention as a measure of weight loss

    Adipose tissue mass volume as measured on CT scan

    Time frame: 12 months

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Study locations

1 site
  • University of Mississippi Health Care
    Jackson, Mississippi 39216, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01582685
Lead sponsor
University of Mississippi Medical Center
Responsible party
Natale Sheehan (Assistant Professor of Medicine, University of Mississippi Medical Center) — Principal investigator
First posted
Apr 23, 2012
Start date
Apr 2012
Primary completion
Jun 2014
Completion
Jun 2014
Last update
Dec 2, 2014

Study contacts

Natale Sheehan, MD
principal investigator · University of Mississippi Health Care

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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