Clinical trial NCT05558384: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Overweight and Obesity
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm feasibility pilot
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Recruitment
timeFrame: up to 12 months
measure: Study Adherence
timeFrame: up to 12 months
measure: Intervention Adherence
timeFrame: 15 weeks
Secondary outcomes:
measure: Serum IGF-1
timeFrame: Baseline, Week 15
measure: Estimated VO2max
timeFrame: Baseline, Week 15
measure: Total visceral adiposity
timeFrame: Baseline, Week 15
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Ryan Marker
role: PRINCIPAL_INVESTIGATOR
References: