Nutrition, Exercise, and Breast Cancer Survivorship

January 30, 2017 updated by: Alice S. Ryan, PhD, Baltimore VA Medical Center

Impact of Nutrition and Exercise on Glucose Metabolism, Inflammation, and Body Composition in Older Breast Cancer Survivors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Baltimore VAMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
muscle performance
Time Frame: change in muscle area between baseline and 16 weeks
muscle strength
change in muscle area between baseline and 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
glucose tolerance
Time Frame: change in glucose levels between baseline and 16 weeks
glucose levels
change in glucose levels between baseline and 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baltimore VA Medical Center

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Andrew P Goldberg, M.D., Baltimore VAMC/GRECC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

December 6, 2016

Study Registration Dates

First Submitted

June 25, 2010

First Submitted That Met QC Criteria

June 25, 2010

First Posted (Estimate)

June 28, 2010

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00045555
  • P30AG028747 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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