A Virtually Delivered Exercise Intervention To Mitigate Cognitive Deficits From Radiotherapy In AYAs With Brain Tumors

Brain Tumor Clinical Trial

Official title:

A Virtually Delivered Exercise Intervention To Mitigate Cognitive Deficits From Radiotherapy In AYAs With Brain Tumors

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05554159
• Other study ID #: 2022-0152
• Secondary ID: NCI-2022-08000
• Status: Suspended
• Phase: N/A
• Start date: June 5, 2023
• Est. completion date: February 28, 2027

Study information

• Verified date: June 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To test a new investigational virtual exercise program for adolescents and young adults (AYAs) with brain tumors who plan to receive cranial radiotherapy

Description:

Primary Objective:

Determine the feasibility and acceptability of a virtually supervised exercise intervention compared to control in AYAs with brain tumors undergoing cranial radiotherapy (CRT).

Secondary Objective:

Assess the effect of supervised exercise intervention on the neuroanatomic structure and cognitive function changes in AYAs with brain tumors undergoing CRT.

Exploratory Objective:

Assess the effect of supervised exercise intervention on other brain structure (white matter integrity), cognitive functions (attention, visual learning, psychomotor function, executive function, verbal learning, working memory and clinician-reported neurological exam outcomes), patient-reported health-related quality of life, objectively measured and patient-reported physical activity level, patient-reported dietary recall, objectively measured physical function assessments, and exercise progression (exercise volume). Assess the agreement between physical function tests performed twice virtually.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. completion date: February 28, 2027
• Est. primary completion date: February 28, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 39 Years

Eligibility

Inclusion Criteria:

1. Age 15-39 years old

2. Self-reported diagnosis of a primary benign or malignant brain tumor or confirmed diagnosis of primary benign or malignant brain tumor radiographically or pathologically when available (relapse or newly diagnosed)

3. Plans to receive CRT at MDACC or, if the participant has already started CRT, the participant is eligible if they are within 3 weeks of the start of CRT

4. Received appropriate physician clearance

5. Able to move arms and legs, and ambulate safely

6. Participant is insufficiently active (reports less than 150 minutes of planned moderate-vigorous intensity activity per week in the prior week)

7. Participants and/or guardians are willing and able to provide informed consent

8. Has a smartphone with available space to download additional apps

9. Does not have sensorimotor strip impairment as indicated by the clinical team

10. Has internet access

11. Can receive physical therapy because this is part of the standard of care

12. Participants and/or guardians are willing and able to provide informed consent for protocol PA18-0130 (Pediatric Energy Balance Data Repository Study), companion protocol for the Fitbit application/assessment.

Exclusion Criteria:

1. Non-English speaking

2. Screen failure for exercise safety based on Physical Activity Readiness Questionnaire (PAR-Q).12

3. Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease

4. Recent fracture or acute musculoskeletal injury that precludes ability to participate in supervised exercise training sessions

5. Cognitive and/or major sensory deficits that would impede the completion of research activities and assessments as deemed by the clinical team.

6. Self-reported diagnosis of a metastatic brain tumor or confirmed diagnosis of a metastatic brain tumor radiographically or pathologically when available

7. Self-report of pregnancy

8. Currently enrolled in another physical activity or exercise intervention

9. Prisoners

10. Self-reported pregnancy status

Related Conditions & MeSH terms

• Brain Cancer
• Brain Neoplasms
• Brain Tumor
• Cognition Disorders
• Cognitive Dysfunction

Intervention

Behavioral:
• Standard Fitbit Program
Participants will be given a Fitbit to wear during their participation in this program. Participants will need to wear the Fitbit at least 5 days per week and for at least 10 hours a day. Participants will take part in video calls (through the video conferencing platform Zoom) 1 time a week.
• Virtual Exercise Program
Participants will be given a Fitbit to wear during their participation in this program. Participants will need to wear the Fitbit at least 5 days per week and for at least 10 hours a day. Participants will take part in video calls (through the video conferencing platform Zoom) 1 time a week.

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT)	Scale Score ranges from 0-10; 0-Symptom has not been present 10-The symptom was as bad as you can imagine it could be	Through study completion an average of 1 year.

External Links

•   M D Anderson Cancer Center