Fitness and Nutrition in Glioma

NCT ID: NCT06665373

Last Updated: 2025-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Malignant Glioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Patients Diagnosed with Malignant Glioma

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.

Group Type EXPERIMENTAL

Modified Atkins Diet

Intervention Type BEHAVIORAL

The Atkins diet is a low-carb eating plan that focuses on balancing protein, fat, and carbohydrates.

Fitness Program

Intervention Type BEHAVIORAL

12 weeks of two weekly supervised exercise sessions combined with an individualized home exercise program based on physical capabilities and available equipment.

Interventions

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Modified Atkins Diet

The Atkins diet is a low-carb eating plan that focuses on balancing protein, fat, and carbohydrates.

Intervention Type BEHAVIORAL

Fitness Program

12 weeks of two weekly supervised exercise sessions combined with an individualized home exercise program based on physical capabilities and available equipment.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lee Tessler, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Cathryn Lapierre

Role: CONTACT

646-201-5762

Lee Tessler, MD

Role: CONTACT

516-324-7500

Other Identifiers

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24-00654

Identifier Type: -

Identifier Source: org_study_id

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