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Cancer Survivors Acute Exercise Response 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03903848
Recruitment Status : Not yet recruiting
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Melissa M Markofski, University of Houston

Brief Summary:
The aims of this study examine the immune system, muscle metabolism, and autonomic nervous system response to an acute bout of exercise. Cancer survivors will participate in an acute bout of exercise. Blood samples will be collected before the exercise bout and at two time points after the exercise bout to assess the proposed variables.

Condition or disease Intervention/treatment Phase
Neoplasms Malignant Other: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Immune and Skeletal Muscle Response to an Exercise Session in Cancer Survivors
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise session
One session of physical exercise
Other: Exercise
Single session of treadmill walking and resistance exercise




Primary Outcome Measures :
  1. Exercise-induced response of circulating monocytes [ Time Frame: Pre-exercise, change from pre-exercise to immediately post-exercise, change from pre-exercise to 1hr post-exercise, change from immediately post-exercise to 1hr post-exercise ]
    Circulating serum monocyte phenotype before and after one exercise session

  2. Exercise-induced response of circulating T cells [ Time Frame: Pre-exercise, change from pre-exercise to immediately post-exercise, change from pre-exercise to 1hr post-exercise, change from immediately post-exercise to 1hr post-exercise ]
    Circulating serum T cells phenotype before and after one exercise session

  3. Exercise-induced response of circulating Follistatin [ Time Frame: Pre-exercise, change from pre-exercise to immediately post-exercise, change from pre-exercise to 1hr post-exercise, change from immediately post-exercise to 1hr post-exercise ]
    Circulating serum follistatin before and after one exercise session

  4. Exercise-induced response of circulating GDF-15 [ Time Frame: Pre-exercise, change from pre-exercise to immediately post-exercise, change from pre-exercise to 1hr post-exercise, change from immediately post-exercise to 1hr post-exercise ]
    Circulating serum growth differentiation factor 15 before and after one exercise session


Secondary Outcome Measures :
  1. Body composition [ Time Frame: before exercise ]
    Relative body composition, as calculated from a DEXA scan. Measurement will be used as a descriptive variable and potential covariant

  2. Body weight [ Time Frame: before exercise ]
    Absolute body weight as measured with an eye level beam. Measurement will be used as a descriptive variable and potential covariant



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between the ages of 40-70 years

    • At least two years past detectible cancer (two years disease-free survival)
    • Have received chemotherapy and/or radiation as part of their cancer treatment
    • All cancers were of the organs/non-blood producing tissues (not blood/hematologic cancers) and while they were an adult (no history of pediatric cancer)
    • Meeting ACSM-AHA guidelines for exercise (150 minutes per week of cardiorespiratory fitness type exercises and ~two days per week of resistance training), as confirmed by a combination of a physical activity questionnaire and a cardiorespiratory fitness classification of "good" or higher (age and sex matched)
    • A BMI between 20-33 kg·m-2
    • Able to speak and read English

Exclusion Criteria:

Participants may not:

  • Have any contraindications to moderate to vigorous exercise
  • Have any recent illness or have been instructed not to exercise by a healthcare provider
  • Participants may not have range of motion restrictions that would prevent them from participating in aerobic or resistance training with proper form (they must be ambulatory)
  • Be taking medications (prescription or over the counter) known to influence immune function (including daily NSAID's and beta blockers), cholesterol-lowering medications (statins), drugs that increase bone mass (bisphosphonates), or steroids.
  • Have known cardiovascular, respiratory, metabolic, or renal disease, with the exception of controlled hypertension (as defined by resting BP below 140/90) and/or controlled asthma (self-reported).
  • Be pregnant
  • Be unable to complete all visits (i.e. must not be planning to leave the Houston area long-term before concluding their participation in the study)
  • Fall outside of a BMI range of (20 - 33)
  • Consume alcohol or recreational drugs for 24h prior to visits
  • Participants must not have scheduling conflicts that would prevent them from reporting to the laboratory of integrated physiology 2-3 times over the course of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903848


Contacts
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Contact: Melissa Markofski, PhD 7137436658 mmarkofski@uh.edu

Sponsors and Collaborators
University of Houston
Investigators
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Principal Investigator: Melissa M Markofski University of Houston
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Responsible Party: Melissa M Markofski, Assistant Professor, University of Houston
ClinicalTrials.gov Identifier: NCT03903848    
Other Study ID Numbers: STUDY00001419
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD may be shared if publication journal requires data sharing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Upon publication
Access Criteria: If when submitting manuscript for publication, the journal requires the release of data then the data will be shared (exact method will be consistent with journal policy, but may include inclusion as a supplementary figure or depositing in a data repository suggested by the journal)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms