Influence of Adiposity on IGF-1 and Fitness Response to Exercise in Cancer Survivors

The Influence of Excess Adiposity on Cardiorespiratory, Insulin-like Growth Factor, and Metabolic Responses to a Standardized Aerobic Exercise Program in Cancer Survivors

This is a pilot feasibility study of an investigation of the influence of excess adiposity on cardiorespiratory fitness (CRF), insulin-like growth factor-1 (IGF-1), and metabolic responses to a standardized aerobic exercise program in cancer survivors. This investigation attempts to isolate the influence of adiposity on these responses. We will enroll overweight, obese, and normal weight cancer survivors with a primary diagnosis of breast, prostate, or colorectal cancer who have completed all cancer-related treatment. Participants will engage in a 15-week aerobic exercise intervention with pre- and post-intervention assessments.

Study Overview

• Status: Completed
• Conditions: Cancer; Overweight and Obesity
• Intervention / Treatment: Behavioral: Aerobic Exercise

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Primary cancer diagnosis of breast, prostate, or colorectal cancer
• Completion of all cancer-related treatment > than 6 months prior and < 5 years prior to enrollment

• Ability and willingness to participate in a supervised exercise program

  • All participants will be required to obtain a signed physician clearance to participate in exercise form prior to enrollment

Exclusion Criteria:

• Presence of a secondary active cancer diagnosis or metastatic disease
• Any current cancer treatment (including hormonal treatment) or planned cancer treatment in the next 5 months
• Greater than 100 min of self-reported regular exercise per week
• BMI < 18.5 (underweight)
• Any significant metabolic condition, such as diabetes. Individuals with pre-diabetes or metabolic syndrome will not be excluded, but this information will be recorded.

• Any medical condition that would impact the safety of, or participation in, an exercise program or exercise testing, including:

  • Orthopedic conditions such as advanced osteoarthritis, mobility-limiting amputations or chronic injuries, or mobility-limiting acute orthopedic injuries
  • Advanced rheumatoid arthritis or chronic widespread pain conditions such as fibromyalgia
  • Pulmonary conditions such as chronic obstructive pulmonary disease, emphysema, or interstitial lung disease
  • Known cardiovascular disease, uncontrolled hypertension, or new cardiac event within the past 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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: Aerobic exercise; 15-week standardized aerobic exercise intervention	Behavioral: Aerobic Exercise; A 15-week standardized aerobic exercise intervention.; Frequency: 5 days/wk (2 supervised); Intensity: 50-59% heart rate reserve; Time: 40 min/session (ramp up from 25-40 during first 4 weeks); Type: Aerobic exercise (e.g. treadmill, walking/jogging, cycling, elliptical)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment	Number of participants joining the study per month	up to 12 months
Study Adherence	Percentage of participants completing pre- and post-intervention assessments	up to 12 months
Intervention Adherence	Average percentage of prescribed exercise sessions completed by participants	15 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum IGF-1	Collected via venipuncture	Baseline, Week 15
Estimated VO2max	Maximal oxygen consumption estimated from a 3 minute step test (Tecumseh Step Test)	Baseline, Week 15
Total visceral adiposity	Collected with dual-energy x-ray absorptiometry	Baseline, Week 15

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Ryan Marker, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2023
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: September 19, 2022
• First Submitted That Met QC Criteria: September 23, 2022
• First Posted (Actual): September 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight
• Other Study ID Numbers: 22-0356.ccc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a pilot feasibility investigation. Data may be made available upon request. Future, fully powered investigations with include an IPD.

Drug and device information, study documents

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