Nutrition, Exercise, and Breast Cancer Survivorship
This study is currently recruiting participants.
Verified February 2013 by Baltimore VA Medical Center
Sponsor:
Baltimore VA Medical Center
Collaborator:
Information provided by (Responsible Party):
Andrew P. Goldberg, Baltimore VA Medical Center
ClinicalTrials.gov Identifier:
NCT01151488
First received: June 25, 2010
Last updated: February 21, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer Survivorship Sarcopenia |
Other: Resistance Training Other: Resistance Training + Nutritional Supplementation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Impact of Nutrition and Exercise on Glucose Metabolism, Inflammation, and Body Composition in Older Breast Cancer Survivors |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Breast Cancer
Cancer
Diabetes Medicines
Dietary Supplements
Exercise and Physical Fitness
Vitamin D
U.S. FDA Resources
Further study details as provided by Baltimore VA Medical Center:
Primary Outcome Measures:
- muscle performance [ Time Frame: baseline ] [ Designated as safety issue: No ]muscle area, strength, and function
- muscle performance [ Time Frame: 4 months ] [ Designated as safety issue: No ]muscle area, strength, and function
Secondary Outcome Measures:
- glucose tolerance and insulin sensitivity [ Time Frame: baseline ] [ Designated as safety issue: No ]
- glucose tolerance and insulin sensitivity [ Time Frame: 4 Months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Resistance Training |
Other: Resistance Training
RT 3x/wk for 4 months
Other Name: Exercise
|
| Experimental: Resistance Training + Nutritional Supplementation |
Other: Resistance Training + Nutritional Supplementation
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
Other Name: Exercise and Nutrition
|
Eligibility| Ages Eligible for Study: | 45 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01151488
Contacts
| Contact: Monica C Serra, Ph.D. | 410 605 7000 ext 4199 | monica.serra@va.gov |
| Contact: Lynda Robey, M.S. | 410 605 7000 ext 5446 | lynda.robey@va.gov |
Locations
| United States, Maryland | |
| Baltimore VAMC | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Monica Serra, PhD 410-605-7000 ext 4199 monica.serra@va.gov | |
Sponsors and Collaborators
Baltimore VA Medical Center
Investigators
| Principal Investigator: | Andrew P Goldberg, M.D. | Baltimore VAMC/GRECC |
More Information
Additional Information:
No publications provided
| Responsible Party: | Andrew P. Goldberg, GRECC Director, Professer of Medicine, Baltimore VA Medical Center |
| ClinicalTrials.gov Identifier: | NCT01151488 History of Changes |
| Other Study ID Numbers: | HP-00045555, RFA-DK-04-016 |
| Study First Received: | June 25, 2010 |
| Last Updated: | February 21, 2013 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Breast Neoplasms Sarcopenia Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Muscular Atrophy |
Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Atrophy Pathological Conditions, Anatomical Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013