Nutrition, Exercise, and Breast Cancer Survivorship

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Andrew P. Goldberg, Baltimore VA Medical Center
ClinicalTrials.gov Identifier:
NCT01151488
First received: June 25, 2010
Last updated: September 4, 2014
Last verified: September 2014
  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:


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
Primary Completion Date: August 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01151488

Locations
United States, Maryland
Baltimore VAMC
Baltimore, Maryland, United States, 21201
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: September 4, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Breast Neoplasms
Sarcopenia
Atrophy
Breast Diseases
Muscular Atrophy
Neoplasms
Neoplasms by Site
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Pathological Conditions, Anatomical
Signs and Symptoms
Skin Diseases

ClinicalTrials.gov processed this record on October 20, 2014