Malignant Glioma
Conditions
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.
Interventions
BEHAVIORALModified Atkins Diet
The Atkins diet is a low-carb eating plan that focuses on balancing protein, fat, and carbohydrates.
BEHAVIORALFitness Program
12 weeks of two weekly supervised exercise sessions combined with an individualized home exercise program based on physical capabilities and available equipment.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Short Form (SF)-36 Version 2 Score | Baseline, Week 12 | The SF-36 |
| Number of Participants who Complete Full 12-Week Program | Week 12 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Time to complete 400-meter-long distance corridor walk. |
| Change in 1 Repetition Maximum (1RM) - Chest Press | Baseline, Week 12 | The 1RM for chest press is the maximum weight an individual can perform for a chest press for one repetition. |
| Change in 1 Repetition Maximum (1RM) - Leg Press | Baseline, Week 12 | The 1RM for chest press is the maximum weight an individual can perform for a leg press for one repetition. |
| Change in Satisfaction With Life Scale (SWLS) Score | Baseline, Week 12 | 5-item assessment of satisfaction with life. Each item is rated on a 7-point Likert scale. The total score is the sum of responses and ranges from 5-35; higher scores indicate greater satisfaction. |
| Change in Hospital Anxiety And Depression Scale (HADS) - Anxiety Subscale Score | Baseline, Week 12 | The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score for the Anxiety subscale is the sum of the respective seven items. The total score ranges from 0-21; higher scores indicate greater anxiety. |
| Change in Hospital Anxiety And Depression Scale (HADS) Score | Baseline, Week 12 | The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the items; the total score ranges from 0-42; higher scores indicate greater anxiety and depression. |
| Change in Fatigue Severity Scale (FSS) Score | Baseline, Week 12 | The Fatigue Severity Scale (FSS) is a 9-item questionnaire that measures the severity of fatigue and how it affects a person's lifestyle and activities. Items are rated on a 7-point Likert scale. The total score is the sum of responses and ranges from 9 to 63. A higher score indicates greater fatigue severity. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLee Tessler, MD
NYU Langone Health
Outcome results
None listed