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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
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer

Eligibility Criteria

21 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 19, 2022
    Last Updated
    December 13, 2022
    Sponsor
    University of Colorado, Denver
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    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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