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

Sponsor
University of Colorado, Denver (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05558384
Collaborator
(none)
20
1
22

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Aerobic Exercise
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single-arm feasibility pilotSingle-arm feasibility pilot
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Sep 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Aerobic exercise

15-week standardized aerobic exercise 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)

Outcome Measures

Primary Outcome Measures

  1. Recruitment [up to 12 months]

    Number of participants joining the study per month

  2. Study Adherence [up to 12 months]

    Percentage of participants completing pre- and post-intervention assessments

  3. Intervention Adherence [15 weeks]

    Average percentage of prescribed exercise sessions completed by participants

Secondary Outcome Measures

  1. Serum IGF-1 [Baseline, Week 15]

    Collected via venipuncture

  2. Estimated VO2max [Baseline, Week 15]

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

  3. Total visceral adiposity [Baseline, Week 15]

    Collected with dual-energy x-ray absorptiometry

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Colorado, Denver

Investigators

  • Principal Investigator: Ryan Marker, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT05558384
Other Study ID Numbers:
  • 22-0356.ccc
First Posted:
Sep 28, 2022
Last Update Posted:
Dec 14, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 14, 2022