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Anatomic Stage I Breast Cancer AJCC v8NCT03708055

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

A study testing Exercise Intervention in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by University of Arizona at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 37 to 65 years
What is being tested?
Exercise Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited States
Study dates
24 Jul 2008to 4 Apr 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 37 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The University of Arizona Medical Center-University Campus

    Tucson, Arizona, 85724

Other trials in United States

About this study

Official title: Prevention of Frailty in Breast Cancer Survivors: A Pilot Study

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

  1. 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.

Medical subject headings
Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03708055
Study groupRoleWhat they receive
Prevention (weight bearing exercise program)ExperimentalParticipants undergo a weight bearing exercise program in a group 2 days a week and at home 5 days a week for 8 weeks.
Receives: Behavioral: Exercise Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 9 years

  2. 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.

    Measured: 8 weeks

  3. 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.

    Measured: Up two weeks

  4. 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.

    Measured: Up to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2018
  2. Study start24 Jul 2008
  3. Primary completion4 Apr 2017
  4. Study completion4 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03708055
Sponsor's protocol ID
0800000618
Other IDs
NCI-2018-01888, 0800000618, P30CA023074
Status last verified
Oct 2018
First submitted
9 Oct 2018
Last updated
23 Oct 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Intervention in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by University of Arizona at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reproducibility of muscle activation by subcutaneous fat mass measures. (time frame: Up to 9 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03708055.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.

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