Exercise in Breast Cancer Survivors

NCT01582685 | Withdrawn

• 1 other identifier: 2011-0121
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Obesity

Keywords

Breast Cancer; Obesity; Exercise; Angiogenesis

Outcome Measures

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

  12 months

Secondary Outcomes (2)

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

  12 months

• 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

  12 months

Study Arms (2)

Exercise Group

EXPERIMENTAL

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 Exercise

NO INTERVENTION

These participants will receive standard of care follow up.

Interventions

Exercise BEHAVIORAL

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

Exercise Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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)
• months after completion of therapy (excluding adjuvant endocrine therapy) at time of randomization

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Health Care

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Obesity; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Natale Sheehan, MD

  University of Mississippi Health Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: April 2, 2012
• First Posted: April 23, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 2, 2014

Record last verified: 2014-12

Locations

US (1)