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Trial Title:
Fitness and Nutrition in Glioma
NCT ID:
NCT06665373
Condition:
Malignant Glioma
Conditions: Official terms:
Glioma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Modified Atkins Diet
Description:
The Atkins diet is a low-carb eating plan that focuses on balancing protein, fat, and
carbohydrates.
Arm group label:
Patients Diagnosed with Malignant Glioma
Intervention type:
Behavioral
Intervention name:
Fitness Program
Description:
12 weeks of two weekly supervised exercise sessions combined with an individualized home
exercise program based on physical capabilities and available equipment.
Arm group label:
Patients Diagnosed with Malignant Glioma
Summary:
This is a pilot study assessing the effects of combining a modified Atkins diet with a
physical fitness regimen in patients with malignant glioma. A sample size of 15
participants will be enrolled in a 15-week program consisting of two weekly supervised
exercise sessions combined with an individualized home exercise program and a modified
Atkins diet.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Tissue confirmed diagnosis of high-grade glioma (World Health Organization grade III
or IV)
- Karnofsky Performance Status (KPS) ≥ 70%
- Willing to follow the study intervention and follow-up
- Able to give full informed consent
Exclusion Criteria:
- Currently undergoing initial concurrent radiation/chemotherapy
- Severe medical co-morbidities
- Any medical condition which prohibits moderate to vigorous physical activity (60-85%
HRmax)
- Any medical condition which prohibits a restrictive diet
- Neurological deficit preventing participation in moderate to vigorous physical
activity
- Severe psychiatric illness
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
NYU Langone Health
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Start date:
October 1, 2024
Completion date:
October 2026
Lead sponsor:
Agency:
NYU Langone Health
Agency class:
Other
Source:
NYU Langone Health
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06665373
