Nutrition, Exercise, and Breast Cancer Survivorship

NCT01151488 | Completed DMC

• 2 other identifiers: HP-00045555P30AG028747
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Survivorship; Sarcopenia

Outcome Measures

Primary Outcomes (1)

• muscle performance

  muscle strength

  change in muscle area between baseline and 16 weeks

Secondary Outcomes (1)

• glucose tolerance

  change in glucose levels between baseline and 16 weeks

Study Arms (1)

Resistance Training

EXPERIMENTAL

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

Other: Resistance Training

Interventions

Resistance Training OTHER

RT 3x/wk for 4 months

Also known as: Exercise

Resistance Training

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Baltimore VA Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Baltimore VAMC

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Resistance Training; Exercise

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Andrew P Goldberg, M.D.

  Baltimore VAMC/GRECC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: June 28, 2010
• Study Start: May 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: December 6, 2016
• Last Updated: February 1, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)