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Clinical Trials/NCT01151488
NCT01151488
Completed
N/A

Impact of Nutrition and Exercise on Glucose Metabolism, Inflammation, and Body Composition in Older Breast Cancer Survivors

Baltimore VA Medical Center1 site in 1 country14 target enrollmentMay 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Breast Cancer Survivorship
Sponsor
Baltimore VA Medical Center
Enrollment
14
Locations
1
Primary Endpoint
muscle performance
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The purpose of the study is to examine the effects of resistance training on the reasons (mechanisms) underlying the development of fatigue, muscle weakness and wasting (sarcopenia), and impaired physical functioning (poor balance and walking) associated with breast cancer survivorship.

Detailed Description

Breast cancer is the most frequently diagnosed cancer in women, representing 26% of all female cancers. It is also the second leading cause of cancer related deaths in the US for women. Side effects of the cancer and treatment therapies may result in inactivity and inadequate intakes of various nutrients, including protein and vitamin D, associated with cardiovascular disease (CVD) and type 2 diabetes. High concentrations of systemic and local inflammation correlate well with CVD and diabetes risk. There is substantial evidence to support that incorporating physical activity and nutrition into one's lifestyle can reduce inflammation and, ultimately, the progression to CVD and diabetes. Understanding the role of exercise and diet management in the health of breast cancer survivors will allow us to translate these findings into therapy guidelines.

Registry
clinicaltrials.gov
Start Date
May 2012
End Date
December 6, 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alice S. Ryan, PhD

Professor

Baltimore VA Medical Center

Eligibility Criteria

Inclusion Criteria

  • Histologic evidence of previous breast cancer
  • Three months post active cancer therapy (i.e. radiation/chemotherapy)
  • Non smoker (non smoking for at least 12 months: cigarettes, cigars, pipes)
  • 45-80 years of age
  • Menopause over one year (absence of menses for 12 months or greater)
  • Sedentary lifestyle (structured physical activity \</= 2x per week)
  • BMI \>/=18 and \<50 kg/m2

Exclusion Criteria

  • Unstable lymphedema (no intensive therapy, no recorded 10% change in arm volume or circumference, no more than one lymphedema-related infection requiring antibiotics and no change in ADLs due to a lymphedema exacerbation for the past 3 months)
  • Plans for surgery (e.g., breast reconstruction) during the study period
  • Evidence of recurrent cancer or metastases
  • Symptomatic heart disease, CAD, CHF, or uncontrolled hypertension (SBP over 180 mm HG) unless medically stabilized
  • Abnormal renal function (BUN above 40 mg/dl, Cr above 1.3 mg/dl, CrCl\<60mg/dl)
  • Anemia HCT below 30 mg/dl, platelets below 100,000/cm3
  • History of seizures or taking anti-seizure or anti convulsion medication
  • Untreated dyslipidemia with National Cholesterol ATPIII 10 year cardiac risk score greater than 10% (www.nhlbi.nih.gov/guidelines/cholesterol/atp3upd04.htm)
  • Allergic to lidocaine
  • Abnormal liver function

Outcomes

Primary Outcomes

muscle performance

Time Frame: change in muscle area between baseline and 16 weeks

muscle strength

Secondary Outcomes

  • glucose tolerance(change in glucose levels between baseline and 16 weeks)

Study Sites (1)

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