Clinical trial NCT06799481: Virtual Home-based Exercise Intervention (RISE) to Improve Cancer-Related Cognitive Impairment and Gut Microbiome in Adolescent and Young Adult Brain Tumor Survivors
Official title: Virtually Delivered Home-Based Exercise Intervention on Cognitive Impairment and Gut Microbiome in Adolescent and Young Adult Brain Tumor Survivors: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer-related Cognitive Dysfunction
Primary Brain Neoplasm
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: NRG Oncology
First posted: 2025-01-29
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial evaluates the impact of a research intervention of virtually supervised exercise program (RISE) on cancer-related cognitive impairment (CRCI), physical activity in adolescent and young adult (AYA) brain tumor survivors. This clinical trial also evaluates the impact of RISE on the collection of microorganisms that exist in the intestines (gut microbiome). Up to 45% of AYA brain tumor survivors experience CRCI, including issues with attention and memory. CRCI can have a negative impact on education, independent living and can worsen long-term quality of life. Moderate-intensity levels of exercise, particularly aerobic and resistance training, have been shown to improve cognitive function. Additionally, exercise can change the composition and function of the gut microbiome, which may lead to improved cognitive function. Unfortunately, only about 50% of AYAs with cancer receive exercise information or meet the physical activity recommendations. Tailoring a virtually delivered exercise intervention to meet the unique needs of AYAs may improve access to exercise. Participating in the virtual home-based exercise intervention, RISE, may improve physical activity and cognitive impairment in AYA brain tumor survivors and may also help researchers understand the relationship of exercise on the gut microbiome and cognitive function.

Detailed description: PRIMARY OBJECTIVES:

I. Evaluate the feasibility of conducting a two-site pilot randomized controlled trial (RCT) to test the RISE in AYA brain tumor survivors.

II. Examine the impact of RISE on CRCI (primary) and physical activity (secondary).

EXPLORATORY OBJECTIVE:

I. Explore the impact of RISE on the gut microbiome diversity and composition.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (RISE INTERVENTION): Patients receive access to Physitrack and participate in personalized, progressive aerobic training over 30-40 minutes 3-5 days a week and strength training exercises 2 days a week for 12 weeks. Patients also receive active lifestyle behavior coaching over 10 minutes on 2 days a week for weeks 1-4 and then once weekly for weeks 5-12.

ARM II (ATTENTION CONTROL): Patients receive calls from the trainer once weekly for 12 weeks. Patients also wear a Fitbit for 7 days at baseline to week 12.

After completion of study intervention, patients are followed up at week 18.

Eligibility criteria: Inclusion Criteria:

* Age 15-39 years
* With primary brain tumor with cranial radiotherapy
* 6 months to 4 years post cranial radiotherapy
* Functional Assessment of Cancer Therapy (FACT)-Cognitive Function score \< 60 based on self-report (used among AYAs with non-neural cancer)
* Able to provide informed consent/assent
* Able to walk and receive clearance from a provider to participate based on the Physical Activity Readiness Questionnaire
* Currently engaging in \< 150 minutes of physical activity per week
* Willing to use smartphone-based applications (app)

Exclusion Criteria:

* Secondary malignancies, germline genetic syndrome, or recurrent disease requiring re-irradiation of the brain
* Moderate to severe traumatic brain injury with brain damage beyond that expected from brain tumor and treatment
* Developmental disorders (e.g., autism) or major psychotic illness (e.g., schizophrenia, depression) to avoid confounding impact related to these disorders

Primary outcomes:
measure: Enrollment
timeFrame: Up to 1.5 years
measure: Adherence to research intervention of virtually supervised exercise program (RISE)
timeFrame: Up to 12 weeks
measure: Retention
timeFrame: Up to 12 weeks
measure: Acceptability
timeFrame: Up to 18 weeks
measure: Change in physical activity levels
timeFrame: Baseline up to 18 weeks
measure: Change in cancer-related cognitive impairment
timeFrame: Baseline up to 18 weeks
Secondary outcomes:
measure: Gut microbiome
timeFrame: Up to 18 weeks
measure: Physical function
timeFrame: At baseline and at 12 and 18 weeks
measure: Patient Quality of Life
timeFrame: At baseline and at 12 and 18 weeks
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Jinbing Bai, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: