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Completed

NCT Number: NCT05558384

Influence of Adiposity on IGF-1 and Fitness Response to Exercise 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.

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Key information

Age range

21 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Recruitment

    Time frame: up to 12 months

    Number of participants joining the study per month

  2. Study Adherence

    Time frame: up to 12 months

    Percentage of participants completing pre- and post-intervention assessments

  3. Intervention Adherence

    Time frame: 15 weeks

    Average percentage of prescribed exercise sessions completed by participants

Secondary outcomes

  1. Serum IGF-1

    Time frame: Baseline, Week 15

    Collected via venipuncture

  2. Estimated VO2max

    Time frame: Baseline, Week 15

    Maximal oxygen consumption estimated from a 3 minute step test (Tecumseh Step Test)

  3. Total visceral adiposity

    Time frame: Baseline, Week 15

    Collected with dual-energy x-ray absorptiometry

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 28, 2022
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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