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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer, Overweight and Obesity

Intervention / Treatment
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* Behavioral: Aerobic Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single-arm feasibility pilot
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerobic exercise<br>15-week standardized aerobic exercise intervention | Behavioral: Aerobic Exercise<br>* 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)<br>|

What is the study measuring?
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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 |