Cancer Survivors Acute Exercise Response 1

Neoplasms Malignant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03903848
• Other study ID #: STUDY00001419
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2019
• Source: University of Houston
• Contact: Melissa Markofski, PhD
• Phone: 7137436658
• Email: mmarkofski[@]uh.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Neoplasms Malignant

Intervention

Other:
• Exercise
Single session of treadmill walking and resistance exercise

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Houston

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Body composition	Relative body composition, as calculated from a DEXA scan. Measurement will be used as a descriptive variable and potential covariant	before exercise
Secondary	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