Fitness and Nutrition in Glioma

NCT06665373 | Recruiting

• 1 other identifier: 24-00654
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Glioma

Outcome Measures

Primary Outcomes (2)

• Change in Short Form (SF)-36 Version 2 Score

  The SF-36

  Baseline, Week 12

• Number of Participants who Complete Full 12-Week Program

  Week 12

Secondary Outcomes (9)

• Change in Blood Ketone Levels

  Baseline, Week 12

• Change in Resting Heart Rate

  Baseline, Week 12

• Change in 400-meter Walk Time

  Baseline, Week 12

• Change in 1 Repetition Maximum (1RM) - Chest Press

  Baseline, Week 12

• Change in 1 Repetition Maximum (1RM) - Leg Press

  Baseline, Week 12

Study Arms (1)

Patients Diagnosed with Malignant Glioma

EXPERIMENTAL

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.

Behavioral: Modified Atkins Diet; Behavioral: Fitness Program

Interventions

Modified Atkins Diet BEHAVIORAL

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

Patients Diagnosed with Malignant Glioma

Fitness Program BEHAVIORAL

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

Patients Diagnosed with Malignant Glioma

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Lee Tessler, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cathryn Lapierre

CONTACT

646-201-5762; Cathryn.lapierre@nyulangone.org

Lee Tessler, MD

CONTACT

516-324-7500; Lee.tessler@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 30, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)