Nutrition, Exercise, and Breast Cancer Survivorship

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01151488
Recruitment Status : Completed
First Posted : June 28, 2010
Last Update Posted : February 1, 2017
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Alice S. Ryan, PhD, Baltimore VA Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Survivorship Sarcopenia Other: Resistance Training Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Nutrition and Exercise on Glucose Metabolism, Inflammation, and Body Composition in Older Breast Cancer Survivors
Study Start Date : May 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : December 6, 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Resistance Training
16 weeks of moderate intensity resistance training, 3x/week
Other: Resistance Training
RT 3x/wk for 4 months
Other Name: Exercise

Primary Outcome Measures :
  1. muscle performance [ Time Frame: change in muscle area between baseline and 16 weeks ]
    muscle strength

Secondary Outcome Measures :
  1. glucose tolerance [ Time Frame: change in glucose levels between baseline and 16 weeks ]
    glucose levels

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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% (
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01151488

United States, Maryland
Baltimore VAMC
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Baltimore VA Medical Center
National Institute on Aging (NIA)
Principal Investigator: Andrew P Goldberg, M.D. Baltimore VAMC/GRECC

Responsible Party: Alice S. Ryan, PhD, Professor, Baltimore VA Medical Center Identifier: NCT01151488     History of Changes
Other Study ID Numbers: HP-00045555
P30AG028747 ( U.S. NIH Grant/Contract )
First Posted: June 28, 2010    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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