Overview

This trial is active, not recruiting.

Conditions breast cancer survivorship, sarcopenia
Treatments resistance training, resistance training + nutritional supplementation
Sponsor Baltimore VA Medical Center
Collaborator National Institute on Aging (NIA)
Start date May 2012
End date August 2014
Trial size 100 participants
Trial identifier NCT01151488, HP-00045555, RFA-DK-04-016

Summary

The purpose of the investigators study is to examine the effects of resistance training with and without protein and vitamin D supplementation 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. 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
resistance training Exercise
RT 3x/wk for 4 months
(Experimental)
resistance training + nutritional supplementation Exercise and Nutrition
RT 3x/wk for 4 months Vitamin D repletion with 50,000 IU of Vitamin D2/3 up to 3 x week(until levels are >75 nmol/l; 6-12wks) followed by 6 months maintenance supplementation with 2000 IU Vitamin D3 and up to 1000mg Calcium daily Protein intake of 1.2 g/kg/d

Primary Outcomes

Measure
muscle performance
time frame: baseline
muscle performance
time frame: 4 months

Secondary Outcomes

Measure
glucose tolerance and insulin sensitivity
time frame: baseline
glucose tolerance and insulin sensitivity
time frame: 4 Months

Eligibility Criteria

Female participants from 45 years up to 80 years old.

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 /=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 - 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

Additional Information

Official title Impact of Nutrition and Exercise on Glucose Metabolism, Inflammation, and Body Composition in Older Breast Cancer Survivors
Principal investigator Andrew P Goldberg, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Baltimore VA Medical Center.