Nutrition, Exercise, and Breast Cancer Survivorship

Completed · Not applicable

Conditions studied: Breast Cancer Survivorship, Sarcopenia

In brief

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.

Key facts

Study ID

NCT01151488

Run by

Baltimore VA Medical Center

People needed

14

Starts

2012-05-01

Expected to finish

2016-12-06

Last updated by the study team

2017-02-01

Who can join

Age: 45 and older, up to 80. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• 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, HgA1c>10%
• 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

Where it is running

• Baltimore VAMC — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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