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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05558384
• Other study ID #: 22-0356.ccc
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2024
• Est. completion date: September 30, 2026

Study information

• Verified date: January 2024
• Source: University of Colorado, Denver
• Contact: Jared Scorsone
• Phone: 3037249601
• Email: jared.scorsone[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Overweight
• Overweight and Obesity

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)

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment	Number of participants joining the study per month	up to 12 months
Primary	Study Adherence	Percentage of participants completing pre- and post-intervention assessments	up to 12 months
Primary	Intervention Adherence	Average percentage of prescribed exercise sessions completed by participants	15 weeks
Secondary	Serum IGF-1	Collected via venipuncture	Baseline, Week 15
Secondary	Estimated VO2max	Maximal oxygen consumption estimated from a 3 minute step test (Tecumseh Step Test)	Baseline, Week 15
Secondary	Total visceral adiposity	Collected with dual-energy x-ray absorptiometry	Baseline, Week 15