CancerNCT05558384
Influence of Adiposity on IGF-1 and Fitness Response to Exercise in Cancer Survivors
A study testing Aerobic Exercise in people with Cancer and Overweight and Obesity, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 79 years
- Conditions the study is for
- Cancer, Overweight and Obesity
- What is being tested?
- Aerobic Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2023to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
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
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
- Being tested
- Aerobic Exercise
- Medical subject headings
- Neoplasms, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise | Experimental | 15-week standardized aerobic exercise intervention Receives: Behavioral: Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Number of participants joining the study per month
Measured: up to 12 months
Study Adherence
Percentage of participants completing pre- and post-intervention assessments
Measured: up to 12 months
Intervention Adherence
Average percentage of prescribed exercise sessions completed by participants
Measured: 15 weeks
Secondary outcomes (3)
Serum IGF-1
Collected via venipuncture
Measured: Baseline, Week 15
Estimated VO2max
Maximal oxygen consumption estimated from a 3 minute step test (Tecumseh Step Test)
Measured: Baseline, Week 15
Total visceral adiposity
Collected with dual-energy x-ray absorptiometry
Measured: Baseline, Week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start22 Mar 2023
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm feasibility pilot
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan Marker, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558384
- Sponsor's protocol ID
- 22-0356.ccc
- Status last verified
- Feb 2025
- First submitted
- 19 Sep 2022
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot feasibility investigation. Data may be made available upon request. Future, fully powered investigations with include an IPD.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05558384
- Acronym / sponsor ID
- 22-0356.ccc
- Conditions
- Cancer, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 28 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm feasibility pilot
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Experimental | Behavioral: Aerobic Exercise15-week standardized aerobic exercise intervention |
Who may qualify
- Ages
- 21 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseA 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) | Behavioural | Aerobic exercise |
Primary outcome
Recruitment
Time frame: up to 12 months
Number of participants joining the study per month
Study Adherence
Time frame: up to 12 months
Percentage of participants completing pre- and post-intervention assessments
Intervention Adherence
Time frame: 15 weeks
Average percentage of prescribed exercise sessions completed by participants
3 secondary outcomes
Serum IGF-1
Time frame: Baseline, Week 15
Estimated VO2max
Time frame: Baseline, Week 15
Total visceral adiposity
Time frame: Baseline, Week 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: No. This is a pilot feasibility investigation. Data may be made available upon request. Future, fully powered investigations with include an IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Marker principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise in people with Cancer and Overweight and Obesity, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: up to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.