Cancer Survivors Acute Exercise Response 1

Immune and Skeletal Muscle Response to an Exercise Session in Cancer Survivors

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neoplasms Malignant
• Intervention / Treatment: Other: Exercise

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melissa Markofski, PhD; Phone Number: 7137436658; Email: mmarkofski@uh.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise session; One session of physical exercise	Other: Exercise; Single session of treadmill walking and resistance exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise-induced response of circulating monocytes	Circulating serum monocyte phenotype before and after one exercise session	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
Exercise-induced response of circulating T cells	Circulating serum T cells phenotype before and after one exercise session	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
Exercise-induced response of circulating Follistatin	Circulating serum follistatin before and after one exercise session	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
Exercise-induced response of circulating GDF-15	Circulating serum growth differentiation factor 15 before and after one exercise session	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	Relative body composition, as calculated from a DEXA scan. Measurement will be used as a descriptive variable and potential covariant	before exercise
Body weight	Absolute body weight as measured with an eye level beam. Measurement will be used as a descriptive variable and potential covariant	before exercise

Collaborators and Investigators

• Sponsor: University of Houston
• Investigators: Principal Investigator: Melissa M Markofski, University of Houston

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: April 1, 2019
• First Submitted That Met QC Criteria: April 3, 2019
• First Posted (Actual): April 4, 2019

Study Record Updates

• Last Update Posted (Actual): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 3, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: STUDY00001419

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD may be shared if publication journal requires data sharing
• IPD Sharing Time Frame: Upon publication
• IPD Sharing 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)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No