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

Not Applicable

Completed

• Conditions: Overweight and Obesity; Cancer

• Registration Number: NCT05558384
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-19
• Study First Submitted QC: 2022-09-23
• Study First Posted: 2022-09-28
• Study Start: 2023-03-22
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States