Malignant GliomaNCT06665373
Fitness and Nutrition in Glioma
A study testing Modified Atkins Diet and Fitness Program in people with Malignant Glioma, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Malignant Glioma
- What is being tested?
- Modified Atkins Diet and Fitness Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Investigate the Effects of Combining a Modified Atkins Diet With a Physical Fitness Regimen in Patients Diagnosed With Malignant Glioma
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
- Being tested
- Modified Atkins Diet, Fitness Program
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Atkins DietBehavioural
The Atkins diet is a low-carb eating plan that focuses on balancing protein, fat, and carbohydrates.
Fitness ProgramBehavioural
12 weeks of two weekly supervised exercise sessions combined with an individualized home exercise program based on physical capabilities and available equipment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Modified Atkins Diet; Behavioral: Fitness Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Short Form (SF)-36 Version 2 Score
The SF-36
Measured: Baseline, Week 12
Number of Participants who Complete Full 12-Week Program
Measured: Week 12
Secondary outcomes (9)
Change in Blood Ketone Levels
Measured: Baseline, Week 12
Change in Resting Heart Rate
Measured: Baseline, Week 12
Change in 400-meter Walk Time
Time to complete 400-meter-long distance corridor walk.
Measured: Baseline, Week 12
Change in 1 Repetition Maximum (1RM) - Chest Press
The 1RM for chest press is the maximum weight an individual can perform for a chest press for one repetition.
Measured: Baseline, Week 12
Change in 1 Repetition Maximum (1RM) - Leg Press
The 1RM for chest press is the maximum weight an individual can perform for a leg press for one repetition.
Measured: Baseline, Week 12
Change in Satisfaction With Life Scale (SWLS) Score
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.
Measured: Baseline, Week 12
Change in Hospital Anxiety And Depression Scale (HADS) - Anxiety Subscale Score
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.
Measured: Baseline, Week 12
Change in Hospital Anxiety And Depression Scale (HADS) Score
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.
Measured: Baseline, Week 12
Change in Fatigue Severity Scale (FSS) Score
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.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start1 Oct 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant GliomaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lee Tessler, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665373
- Sponsor's protocol ID
- 24-00654
- Status last verified
- Jun 2026
- First submitted
- 29 Oct 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified data will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Investigate the Effects of Combining a Modified Atkins Diet With a Physical Fitness Regimen in Patients Diagnosed With Malignant Glioma
- ClinicalTrials.gov ID
- NCT06665373
- Acronym / sponsor ID
- 24-00654
- Conditions
- Malignant Glioma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Diagnosed with Malignant Glioma | Experimental | Behavioral: Modified Atkins Diet, Behavioral: Fitness ProgramPatients 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Atkins DietThe Atkins diet is a low-carb eating plan that focuses on balancing protein, fat, and carbohydrates. | Behavioural | Patients Diagnosed with Malignant Glioma |
| Fitness Program12 weeks of two weekly supervised exercise sessions combined with an individualized home exercise program based on physical capabilities and available equipment. | Behavioural | Patients Diagnosed with Malignant Glioma |
Primary outcome
Change in Short Form (SF)-36 Version 2 Score
Time frame: Baseline, Week 12
The SF-36
Number of Participants who Complete Full 12-Week Program
Time frame: Week 12
9 secondary outcomes
Change in Blood Ketone Levels
Time frame: Baseline, Week 12
Change in Resting Heart Rate
Time frame: Baseline, Week 12
Change in 400-meter Walk Time
Time frame: Baseline, Week 12
Change in 1 Repetition Maximum (1RM) - Chest Press
Time frame: Baseline, Week 12
Change in 1 Repetition Maximum (1RM) - Leg Press
Time frame: Baseline, Week 12
Change in Satisfaction With Life Scale (SWLS) Score
Time frame: Baseline, Week 12
Change in Hospital Anxiety And Depression Scale (HADS) - Anxiety Subscale Score
Time frame: Baseline, Week 12
Change in Hospital Anxiety And Depression Scale (HADS) Score
Time frame: Baseline, Week 12
Change in Fatigue Severity Scale (FSS) Score
Time frame: Baseline, Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No. Deidentified data will not be shared with other researchers
Related trials for Malignant Glioma
RecruitingPhase 1
A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma
Glioblastoma Multiforme of Brain, Glioma
RecruitingEarly Phase 1
Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma
Diffuse Glioma, Malignant Glioma
Active, not recruitingPhase 1
Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma
Recurrent Glioblastoma, Recurrent Malignant Glioma
Active, not recruitingPhase 1/2
A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)
Malignant Glioma
RecruitingPhase 2
Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors
High Grade Glioma, CNS Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee Tessler, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Atkins Diet and Fitness Program in people with Malignant Glioma, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Short Form (SF)-36 Version 2 Score (time frame: Baseline, Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.