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

NCT05558384 | Completed DMC

• 1 other identifier: 22-0356.ccc
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Overweight and Obesity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Serum IGF-1

  Baseline, Week 15

• Estimated VO2max

  Baseline, Week 15

• Total visceral adiposity

  Baseline, Week 15

Study Arms (1)

Aerobic exercise

EXPERIMENTAL

15-week standardized aerobic exercise intervention

Behavioral: Aerobic Exercise

Interventions

Aerobic Exercise BEHAVIORAL

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)

Aerobic exercise

Eligibility Criteria

• Age: 21 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Neoplasms; Overweight; Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ryan Marker

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm feasibility pilot

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 28, 2022
• Study Start: March 22, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)