Influence of Adiposity on IGF-1 and Fitness Response to Exercise in Cancer Survivors
Primary Purpose
Cancer, Overweight and Obesity
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Aerobic Exercise
Sponsored by

About this trial
This is an interventional treatment trial for Cancer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Aerobic exercise
Arm Description
15-week standardized aerobic exercise intervention
Outcomes
Primary Outcome Measures
Recruitment
Number of participants joining the study per month
Study Adherence
Percentage of participants completing pre- and post-intervention assessments
Intervention Adherence
Average percentage of prescribed exercise sessions completed by participants
Secondary Outcome Measures
Serum IGF-1
Collected via venipuncture
Estimated VO2max
Maximal oxygen consumption estimated from a 3 minute step test (Tecumseh Step Test)
Total visceral adiposity
Collected with dual-energy x-ray absorptiometry
Full Information
NCT ID
NCT05558384
First Posted
September 19, 2022
Last Updated
December 13, 2022
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT05558384
Brief Title
Influence of Adiposity on IGF-1 and Fitness Response to Exercise in Cancer Survivors
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Overweight and Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-arm feasibility pilot
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aerobic exercise
Arm Type
Experimental
Arm Description
15-week standardized aerobic exercise intervention
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Exercise
Intervention Description
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 Outcome Measure Information:
Title
Recruitment
Description
Number of participants joining the study per month
Time Frame
up to 12 months
Title
Study Adherence
Description
Percentage of participants completing pre- and post-intervention assessments
Time Frame
up to 12 months
Title
Intervention Adherence
Description
Average percentage of prescribed exercise sessions completed by participants
Time Frame
15 weeks
Secondary Outcome Measure Information:
Title
Serum IGF-1
Description
Collected via venipuncture
Time Frame
Baseline, Week 15
Title
Estimated VO2max
Description
Maximal oxygen consumption estimated from a 3 minute step test (Tecumseh Step Test)
Time Frame
Baseline, Week 15
Title
Total visceral adiposity
Description
Collected with dual-energy x-ray absorptiometry
Time Frame
Baseline, Week 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jared Scorsone
Phone
3037249601
Email
jared.scorsone@cuanschutz.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Marker
Phone
3037240819
Email
ryan.marker@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Marker
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
This is a pilot feasibility investigation. Data may be made available upon request. Future, fully powered investigations with include an IPD.
Learn more about this trial
Influence of Adiposity on IGF-1 and Fitness Response to Exercise in Cancer Survivors
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