RecruitingNot ApplicableNCT06725953

Remote Physical Activity Programming to Improve Outcomes in Cancer Survivors With and Without Type 2 Diabetes

Cerebrovascular, Cognitive, Pro-Inflammatory, and Cardiometabolic Outcomes in Cancer Survivors With and Without Type II Diabetes Reporting Chemo-Brain: Baseline Differences and Impact of Activity


Sponsor

University of Oklahoma

Enrollment

38 participants

Start Date

Mar 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The growing U.S. cancer survivor population is projected to hit 26M by 2040. Chemotherapy represents an effective cancer treatment but can diminish cancer survivors' quality of life-particularly cognitive function-through select pathophysiological processes. Research on chemotherapy-induced cognitive impairment (hereafter, 'chemo-brain') is therefore critical. Chemotherapy disrupts immune system function and antioxidant regulation, causing inflammatory molecule release and damaging the brain's blood vessels. The brain's vascular function and, possibly, its neurons, are subsequently impaired-likely contributing to chemo-brain. Type 2 diabetes (T2D), a common cancer survivor comorbidity, shares underlying pathophysiology with chemo-brain. T2D-related insulin resistance can precipitate repeated high blood sugar episodes which increase inflammatory molecule release. In individuals with T2D without cancer, negative relationships are observed between inflammatory molecule concentrations and the brain's vascular and/or cognitive function. Cancer survivors with T2D might thus have higher chemo-brain risk than those without T2D. Yet, more research must compare how the brain's vascular function, as well as cognitive, inflammatory, and cardiometabolic indices, differ between these groups. Physical activity (PA) counteracts chemo-brain's and T2D's pathophysiology, with higher PA/fitness resulting in better vascular function of the brain, lower inflammatory molecule concentrations, and improved insulin sensitivity. We are therefore conducting a 30-participant quasi-experimental pilot study in cancer survivors with (cases) and without (controls) T2D. We will first investigate between-group differences in the brain's vascular function as well as cognitive, inflammatory, cardiometabolic, and epigenetic outcomes. We will then examine between-group changes in these outcomes and select psychosocial metrics during a 12-week technology-based PA program-potentially further elucidating involved mechanisms.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a remote (online) exercise program to improve cognitive problems (such as brain fog and memory issues) in cancer survivors who have experienced treatment-related cognitive difficulties, including those with type 2 diabetes. **You may be eligible if...** - Age 18 or older - Can speak and read English - Completed chemotherapy within the last 3 years for a non-brain cancer - Currently experiencing self-reported cognitive difficulties (e.g., brain fog, memory issues) after treatment - Able to give informed consent **You may NOT be eligible if...** - Had central nervous system (brain or spine) cancer - Have physical limitations preventing safe exercise participation - Are currently enrolled in another exercise intervention study - Cannot access remote (online) program technology Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALSocial Cognitive Theory-based, Technology-delivered Physical Activity Program

Participants will engage in a 12-week program of aerobic and muscle-strengthening physical activity. This program will be delivered remotely via two smartphone applications--one for providing health education, goal setting, and journaling features and the other for delivery of the physical activity program in a highly-personalized and HIPAA-compliant manner. Participants will receive a Fitbit to track their activity and resistance bands to use during their resistance training physical activity. All program components will be based in the Social Cognitive Theory and will target improving participants' physiological and psychological health outcomes.


Locations(1)

University of Oklahoma Health Sciences

Oklahoma City, Oklahoma, United States

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NCT06725953


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