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Weight Bearing Exercise in Preventing Frailty in Stage I-IIIA Breast Cancer Survivors

Primary Purpose

Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Intervention
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anatomic Stage I Breast Cancer AJCC v8

Eligibility Criteria

37 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Post-menopausal (12 months without menstrual period: naturally, surgically, by hormone suppression).
  • History of early stage breast cancer (stage I, II, IIIa).
  • At least 6 months from chemotherapy.
  • May be receiving hormonal therapy during the study.
  • Currently disease-free, including a negative mammogram within 1 year.
  • Body mass index (BMI) between 25 and 40kg/m^2.
  • In general good health with no acute or chronic disease that could worsen with weight bearing exercise.
  • Not currently on a prescribed diet nor reporting weight loss of > 10 pounds (lbs) in previous 3 months.
  • Not currently participating in physical activity (PA) independently or a structured program (performing < 120 min of low-intensity, low-impact exercise per week; and no weightlifting or similar physical activity).
  • Ability to participate in physical activity, not limited by severe disability (e.g., severe arthritic conditions); chronic back pain, or history or presence of diseases for which increased physical activity would not be advised.
  • No severe chronic disease, other than breast cancer (e.g., human immunodeficiency virus/acquired immunodeficiency syndrome [HIV/AIDS], kidney failure, liver failure, chronic obstructive pulmonary disease, congestive heart failure, Alzheimer?s, unstable angina, uncontrolled asthma, uncontrolled diabetes, uncontrolled hypertension).
  • No implanted cardiac pacemaker, cardiac defibrillator, or other implanted electronic medical equipment.
  • No history of drug or alcohol abuse.
  • Able to remain in a lying or sitting position for an extended period (> 30 minutes).
  • No history or presence of a significant psychiatric disorder or any other condition that would interfere with participation in the trial.
  • Medical clearance by treating physician.
  • Willing to discontinue nonsteroidal antiinflammatory drug (NSAID) use, except Tylenol and baby aspirin (80mg), 1 week prior to blood draws.
  • Willing to maintain body weight during the study.
  • Can be reached by telephone.
  • Willing to complete consent process and sign informed consent form.

Sites / Locations

  • The University of Arizona Medical Center-University Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prevention (weight bearing exercise program)

Arm Description

Participants undergo a weight bearing exercise program in a group 2 days a week and at home 5 days a week for 8 weeks.

Outcomes

Primary Outcome Measures

Reproducibility of muscle activation by subcutaneous fat mass measures.
Demonstrate reproducibility of forearm muscle activation and subcutaneous fat measures in a healthy convenience sample/population (N= 10). Standard anthropometric measurements (height, weight, waist, hip and arm circumferences) will be taken at baseline and 8weeks. A total body dual energy X-ray absorptiometry (DXA) scan, with an effective radiation dose of about 0.01 mSv, which is about the same as background radiation in one day according to the American College of Radiology (http://www.radiologyinfo.org/en/safety/index.cfm?pg=sfty_xray#3), will be used to determine fat mass and fat free mass at these same time-points. Skeletal muscle mass will be determined by using both appendicular lean mass/height2 method and the residuals model from the Health ABC Study.
Amount of lean muscle as determined by using both appendicular lean mass/height2 method and the residuals model from the Health ABC Study.
Skeletal muscle mass will be determined by using both appendicular lean mass/height2 method and the residuals model from the Health ABC Study.
Reproducibility of signal attenuation using electromyography (EMG)
Maximal isometric muscle activation of the forearm flexors by electromyography (EMG) will be assessed by a pair of surface electrodes (plus 1 ground), to minimize participant burden. EMG data will be amplified and recorded by BIOPAC Systems MP35, 4-channel acquisition system and BSL Pro 3.7 software (BIOPAC Systems, Inc. Goleta, CA), during each of 4, 2-second, repetitions on the 100kg hand grip isometric dynamometer, integrated into the BIOPAC system. Sampling rate and acquisition length will be standardized. The I-beam tool will select the initiation of and conclusion of each contraction. Contraction 1 for each participant will be used for exercise familiarization and dropped, contractions 2-4 will be averaged to for maximal isometric muscle activation (mV). Normally, the non-dominant arm would be evaluated, but since this particular population may have functional limitations on either or both sides due to surgery (i.e. lymphectomy or mastectomy), both arms will be measured.
Level of strength as measured by 8-12 repetition maximum (RM) and by hand grip dynamometer.
A standard submaximal test of strength, 8-12 repetition maximum (RM) will used to evaluate strength and maintain loads in the lower body, which has been safe and effective in previous studies. Strength by hand grip dynamometer will also be measured at baseline and 8wks post-training.

Secondary Outcome Measures

Full Information

First Posted
October 9, 2018
Last Updated
October 19, 2018
Sponsor
University of Arizona
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03708055
Brief Title
Weight Bearing Exercise in Preventing Frailty in Stage I-IIIA Breast Cancer Survivors
Official Title
Prevention of Frailty in Breast Cancer Survivors: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 24, 2008 (Actual)
Primary Completion Date
April 4, 2017 (Actual)
Study Completion Date
April 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This trial studies how well weight bearing exercise works in preventing frailty in stage I-IIIA breast cancer survivors. Weight bearing exercise, including muscle-strengthening, aerobic, flexibility, and balance exercises, can decrease fat and increase muscle, which may lead to reduced frailty.
Detailed Description
PRIMARY OBJECTIVES: I. Demonstrate reproducibility of forearm muscle activation and subcutaneous fat measures in a healthy convenience sample/population (N= 10). II. Demonstrate that measures of muscle activation and signal attenuation by subcutaneous fat mass can be conducted in a systematic and reproducible fashion in breast cancer survivors prior to and following weight bearing exercise training. III. In a cross sectional analysis, describe the level of lean muscle mass, muscle activation, strength, insulin resistance, inflammatory cytokines and growth factors, and inter-individual variability in breast cancer survivors prior to training. IV. Describe the level of lean muscle mass, muscle activation, strength, insulin resistance, inflammatory cytokines (such as IL-6, CRP and others), and growth factors (such as myostatin, IGF-1, IGFBP-3 and others) in breast cancer survivors following weight bearing exercise training. V. Evaluate the influence of genetic variability on response to prescribed training in breast cancer survivors. OUTLINE: Participants undergo a weight bearing exercise program in a group 2 days a week and at home 5 days a week for 8 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Cancer Survivor, Overweight, Postmenopausal, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Prevention (weight bearing exercise program)
Arm Type
Experimental
Arm Description
Participants undergo a weight bearing exercise program in a group 2 days a week and at home 5 days a week for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
Undergo weight bearing exercise program
Primary Outcome Measure Information:
Title
Reproducibility of muscle activation by subcutaneous fat mass measures.
Description
Demonstrate reproducibility of forearm muscle activation and subcutaneous fat measures in a healthy convenience sample/population (N= 10). Standard anthropometric measurements (height, weight, waist, hip and arm circumferences) will be taken at baseline and 8weeks. A total body dual energy X-ray absorptiometry (DXA) scan, with an effective radiation dose of about 0.01 mSv, which is about the same as background radiation in one day according to the American College of Radiology (http://www.radiologyinfo.org/en/safety/index.cfm?pg=sfty_xray#3), will be used to determine fat mass and fat free mass at these same time-points. Skeletal muscle mass will be determined by using both appendicular lean mass/height2 method and the residuals model from the Health ABC Study.
Time Frame
Up to 9 years
Title
Amount of lean muscle as determined by using both appendicular lean mass/height2 method and the residuals model from the Health ABC Study.
Description
Skeletal muscle mass will be determined by using both appendicular lean mass/height2 method and the residuals model from the Health ABC Study.
Time Frame
8 weeks
Title
Reproducibility of signal attenuation using electromyography (EMG)
Description
Maximal isometric muscle activation of the forearm flexors by electromyography (EMG) will be assessed by a pair of surface electrodes (plus 1 ground), to minimize participant burden. EMG data will be amplified and recorded by BIOPAC Systems MP35, 4-channel acquisition system and BSL Pro 3.7 software (BIOPAC Systems, Inc. Goleta, CA), during each of 4, 2-second, repetitions on the 100kg hand grip isometric dynamometer, integrated into the BIOPAC system. Sampling rate and acquisition length will be standardized. The I-beam tool will select the initiation of and conclusion of each contraction. Contraction 1 for each participant will be used for exercise familiarization and dropped, contractions 2-4 will be averaged to for maximal isometric muscle activation (mV). Normally, the non-dominant arm would be evaluated, but since this particular population may have functional limitations on either or both sides due to surgery (i.e. lymphectomy or mastectomy), both arms will be measured.
Time Frame
Up two weeks
Title
Level of strength as measured by 8-12 repetition maximum (RM) and by hand grip dynamometer.
Description
A standard submaximal test of strength, 8-12 repetition maximum (RM) will used to evaluate strength and maintain loads in the lower body, which has been safe and effective in previous studies. Strength by hand grip dynamometer will also be measured at baseline and 8wks post-training.
Time Frame
Up to 8 weeks
Other Pre-specified Outcome Measures:
Title
Measure changes in biomarkers, i.e. insulin resistance, inflammatory cytokines (such as IL-6, CRP and others), and growth factors (such as myostatin, IGF-1, IGFBP-3 and others).
Description
Insulin, insulin resistance (homeostasis model of insulin resistance, HOMA-IR), growth factors and pro-inflammatory cytokines will be evaluated. Assays will be performed in duplicate for insulin and in triplicate for glucose, based on prior assay experience, with baseline and 8 wk samples for each individual run within the same assay. An Insulin Radioimmunoassay Kit will be used to quantify fasting insulin levels.Determination of glucose will be performed by colorimetric assay via the glucose oxidase method and spectrophotometer. Past intra- and inter-assay CVs were 5% and 8% for glucose measures respectively. HOMA-IR = insulin0 (uU/ml)*glucose0 (mmol/l)) / 22.5. Highly sensitive ELISA kits will be used to measure circulating cytokines, such as IL-6 or CRP and growth factors, such as IGF-1 in duplicate. Controls for each assay will be run concurrently on each plate. Each assay will be run with intra and inter assay CVs of <5% and <10% respectively.
Time Frame
Up to 8 weeks
Title
Quantitative and qualitative analysis of DNA.
Description
DNA extraction from blood buffy coat or whole blood will be performed using the FlexiGene DNA Kit following the protocol for Isolation of DNA from 100-500µl Buffy Coat. Quantitative and qualitative DNA analysis will be performed by the Quant-iT™ PicoGreen® dsDNA Assay Kit and by performing 558bp polymerase chain reaction (PCR) and separation by gel electrophoresis on a 2% agarose gel, stained with ethidium bromide for visualization. Determination of polymorphisms related to body composition, exercise or chronic disease will be performed using TaqMan® Pre-Designed SNP Genotyping Assays with allelic discrimination by the ABI PRISMTM 7700 Sequence Detector. If TaqMan technology is not suitable for a particular polymorphism, then simple multiplex PCR with primers designed by Midland Chemicals will be performed and allelic determination will be conducted by ethidium bromide visualization on agarose gel. Universal PCR thermocycling conditions will be used.
Time Frame
Up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
37 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Post-menopausal (12 months without menstrual period: naturally, surgically, by hormone suppression). History of early stage breast cancer (stage I, II, IIIa). At least 6 months from chemotherapy. May be receiving hormonal therapy during the study. Currently disease-free, including a negative mammogram within 1 year. Body mass index (BMI) between 25 and 40kg/m^2. In general good health with no acute or chronic disease that could worsen with weight bearing exercise. Not currently on a prescribed diet nor reporting weight loss of > 10 pounds (lbs) in previous 3 months. Not currently participating in physical activity (PA) independently or a structured program (performing < 120 min of low-intensity, low-impact exercise per week; and no weightlifting or similar physical activity). Ability to participate in physical activity, not limited by severe disability (e.g., severe arthritic conditions); chronic back pain, or history or presence of diseases for which increased physical activity would not be advised. No severe chronic disease, other than breast cancer (e.g., human immunodeficiency virus/acquired immunodeficiency syndrome [HIV/AIDS], kidney failure, liver failure, chronic obstructive pulmonary disease, congestive heart failure, Alzheimer?s, unstable angina, uncontrolled asthma, uncontrolled diabetes, uncontrolled hypertension). No implanted cardiac pacemaker, cardiac defibrillator, or other implanted electronic medical equipment. No history of drug or alcohol abuse. Able to remain in a lying or sitting position for an extended period (> 30 minutes). No history or presence of a significant psychiatric disorder or any other condition that would interfere with participation in the trial. Medical clearance by treating physician. Willing to discontinue nonsteroidal antiinflammatory drug (NSAID) use, except Tylenol and baby aspirin (80mg), 1 week prior to blood draws. Willing to maintain body weight during the study. Can be reached by telephone. Willing to complete consent process and sign informed consent form.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Bea
Organizational Affiliation
The University of Arizona Medical Center-University Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Arizona Medical Center-University Campus
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States

12. IPD Sharing Statement

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Weight Bearing Exercise in Preventing Frailty in Stage I-IIIA Breast Cancer Survivors

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