Fitness and Nutrition in Glioma

NYU Langone Health

Status: Enrolling

Conditions: Malignant Glioma

Treatments: Behavioral: Fitness Program; Behavioral: Modified Atkins Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06665373

24-00654

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Patients Diagnosed with Malignant Glioma

Experimental group

Description:

Patients will participate in a 15-week program consisting of two weekly supervised exercise sessions combined with an individualized home exercise program and a modified Atkins diet.

Treatment:

Behavioral: Modified Atkins Diet

Behavioral: Fitness Program