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Nutrition, Exercise, and Breast Cancer Survivorship

Primary Purpose

Breast Cancer Survivorship, Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistance Training
Sponsored by
Baltimore VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer Survivorship

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Baltimore VAMC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Resistance Training

Arm Description

16 weeks of moderate intensity resistance training, 3x/week

Outcomes

Primary Outcome Measures

muscle performance
muscle strength

Secondary Outcome Measures

glucose tolerance
glucose levels

Full Information

First Posted
June 25, 2010
Last Updated
January 30, 2017
Sponsor
Baltimore VA Medical Center
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT01151488
Brief Title
Nutrition, Exercise, and Breast Cancer Survivorship
Official Title
Impact of Nutrition and Exercise on Glucose Metabolism, Inflammation, and Body Composition in Older Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
December 6, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baltimore VA Medical Center
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Survivorship, Sarcopenia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resistance Training
Arm Type
Experimental
Arm Description
16 weeks of moderate intensity resistance training, 3x/week
Intervention Type
Other
Intervention Name(s)
Resistance Training
Other Intervention Name(s)
Exercise
Intervention Description
RT 3x/wk for 4 months
Primary Outcome Measure Information:
Title
muscle performance
Description
muscle strength
Time Frame
change in muscle area between baseline and 16 weeks
Secondary Outcome Measure Information:
Title
glucose tolerance
Description
glucose levels
Time Frame
change in glucose levels between baseline and 16 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew P Goldberg, M.D.
Organizational Affiliation
Baltimore VAMC/GRECC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baltimore VAMC
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Nutrition, Exercise, and Breast Cancer Survivorship

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