RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-10
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06725953

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. ≥18 years old
  2. 2. ability to speak/read English
  3. 3. ability to provide informed consent
  4. 4. underwent treatment within the last three years for a non-central nervous system-related cancer with said treatment having included chemotherapy
  5. 5. self-reported cognitive difficulties following cancer treatment
  6. 6. For CS+T2D: current T2D diagnosis as classified by a fasted blood glucose of ≥126 mg/dL, 2-hour oral glucose tolerance test of ≥200 mg/dL, HbA1c level of ≥6.5%, or use of medications to treat hyperglycemia (e.g., Metformin) or For CS: no current T2D diagnosis as classified by a fasted blood glucose \<100 mg/dL, 2-hour oral glucose tolerance test \<140 mg/dL, or HbA1c level of \<5.7%. Presence/absence of T2D to be confirmed preferentially via physician's documentation
  7. 7. own smartphone and/or computer with internet access
  8. 8. willing to participate in the 12-week remotely-delivered PA program
  1. 1. reporting a Physical Activity Readiness Questionnaire (2017 PAR-Q) score that indicates PA may potentially be unsafe, unless the participant produces a signed doctor's note. We will define 2017 PAR-Q+ scores as indicating that PA may potentially be unsafe as responding "Yes" to any of the follow-up questions except \[1\] if the individual indicates that they have high blood pressure but subsequent responses indicate that they do not have problems keeping it under control and that their resting blood pressure is less than 160/90 mmHg, and \[2\] if the individual indicates that they have a metabolic condition but subsequent responses indicate that they do not have problems controlling their blood sugar levels, do not any experience signs or symptoms of hypoglycemia, and do not have any signs of symptoms of listed diabetes complications)
  2. 2. engaging in ≥75 min/week of vigorous-intensity PA, ≥150 min/week of moderate-intensity PA, or an equivalent combination of both over the last 3 months
  3. 3. currently a prisoner, pregnant, or planning to become pregnant during study.

Contacts and Locations

Study Contact

Zachary C Pope, PhD
CONTACT
405-271-8001
zachary-pope@ouhsc.edu
Mikhail Kellawan, PhD
CONTACT
405-325-5211
kellawan@ou.edu

Principal Investigator

Zachary C Pope, PhD
PRINCIPAL_INVESTIGATOR
University of Oklahoma Health Sciences
Mikhail Kellawan, PhD
PRINCIPAL_INVESTIGATOR
University of Oklahoma, Department of Health and Exercise Science
Andriy Yabluchanskiy, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Oklahoma Health Sciences

Study Locations (Sites)

University of Oklahoma Health Sciences
Oklahoma City, Oklahoma, 73104
United States

Collaborators and Investigators

Sponsor: University of Oklahoma

  • Zachary C Pope, PhD, PRINCIPAL_INVESTIGATOR, University of Oklahoma Health Sciences
  • Mikhail Kellawan, PhD, PRINCIPAL_INVESTIGATOR, University of Oklahoma, Department of Health and Exercise Science
  • Andriy Yabluchanskiy, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Oklahoma Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-10
Study Completion Date2026-05

Study Record Updates

Study Start Date2025-03-10
Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

  • Aerobic Physical Activity
  • Resistance Training
  • Wearable Devices
  • Smartphone Applications
  • Cancer Survivors
  • Chemo-Brain
  • Health Outcomes

Additional Relevant MeSH Terms

  • Cancer Survivorship
  • Chemotherapy Side Effects