Nutrition, Exercise, and Breast Cancer Survivorship

NCT ID: NCT01151488

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2016-12-06

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.

Conditions

Breast Cancer Survivorship; Sarcopenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Resistance Training

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

Group Type: EXPERIMENTAL

Resistance Training

Intervention Type: OTHER

RT 3x/wk for 4 months

Interventions

Resistance Training

RT 3x/wk for 4 months

Intervention Type: OTHER

Other Intervention Names

Exercise

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Baltimore VA Medical Center

FED

Sponsor Role: lead

Responsible Party

Alice S. Ryan, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew P Goldberg, M.D.

Role: PRINCIPAL_INVESTIGATOR

Baltimore VAMC/GRECC

Locations

Baltimore VAMC

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

P30AG028747

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HP-00045555

Identifier Type: -

Identifier Source: org_study_id