Clinical trial NCT03903848: Cancer Survivors Acute Exercise Response 1
Official title: Immune and Skeletal Muscle Response to an Exercise Session in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neoplasms Malignant
Lead sponsor: University of Houston
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 18
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Exercise-induced response of circulating monocytes
timeFrame: 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
measure: Exercise-induced response of circulating T cells
timeFrame: 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
measure: Exercise-induced response of circulating Follistatin
timeFrame: 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
measure: Exercise-induced response of circulating GDF-15
timeFrame: 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 outcomes:
measure: Body composition
timeFrame: before exercise
measure: Body weight
timeFrame: before exercise
Other outcomes:
Locations:
Study officials:
affiliation: University of Houston
name: Melissa M Markofski
role: PRINCIPAL_INVESTIGATOR
References: