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

45 Years
80 Years
Open (Enrolling)
Breast Cancer Survivorship, Sarcopenia

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Trial Information

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

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
- 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% (

- Allergic to lidocaine

- Abnormal liver function

- Abnormal response to exercise test (ST segment depression greater than 2mm, chest
pain, significant arrhythmias, extreme shortness of breath, cyanosis, exercising BP
above 240/120 mm HG, or other contraindications to exercise) confirmed with further
diagnostic evaluations.

- Type 1 diabetes; insulin treatment for diabetes, poorly controlled diabetes,

- Taking oral steroids, warfarin, or other medications interfering with fat/muscle
metabolism that may not be safely discontinued temporarily for specific procedures
(i.e. for 72 hours prior)

- MMSE below 24, dementia, or unstable clinical depression by exam

- Chronic pulmonary disease (on supplemental O2)

- Metal implants or devices (i.e. pacemaker) if undergoing CT scan

- Participant is, in the opinion of the investigator, unable to adhere to the study
protocol due to medical or orthopedic conditions that limit ability to exercise or
travel to the Baltimore VA for protocol procedures

- Aerobically trained with VO2max greater than 2 SD above age-adjusted mean

- Alcohol consumption greater than 3 oz. liquor, 3x4 oz glass of wine, or 2x12 oz beers
per day, by self report

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

muscle performance

Outcome Description:

muscle area, strength, and function

Outcome Time Frame:


Safety Issue:


Principal Investigator

Andrew P Goldberg, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baltimore VAMC/GRECC


United States: Federal Government

Study ID:




Start Date:

May 2012

Completion Date:

July 2015

Related Keywords:

  • Breast Cancer Survivorship
  • Sarcopenia
  • Breast Neoplasms
  • Sarcopenia



Baltimore VAMC Baltimore, Maryland  21201