Malignant TumorsNCT01092247
The Effect of Ketogenic Diet on Malignant Tumors- Recurrence and Progress
A study testing Nutritional support with Standard diet and Nutritional intervention with the Ketogenic diet in people with Malignant Tumors, run by Tel-Aviv Sourasky Medical Center.
Trial summary
The aim of the study is, to study the efficacy of the ketogenic diet in delaying or preventing recurrence and tumor growth progression of patients who have been previously treated by concomitant chemoradiotherapy (6 months) for high-grade glial tumors. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Malignant Tumors
- What is being tested?
- Nutritional support with Standard diet and Nutritional intervention with the Ketogenic diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consenting adults aged ≥ 18 years.
- Recurrent or progressive high grade glioma after failure of at least one line of standard oncological treatment.
- Gliomatosis cerebri, including patients declining radiation treatment.
Who cannot join
- Patients with malignant tumors who are receiving treatment at the time of the recruitment.
- Early termination - patients who will wish to stop their participation in the trial will discontinue the ketogenic diet and return to their usual diet.
Trial locations and contacts
No sites are listed yet.
About this study
The aim of the study is, to study the efficacy of the ketogenic diet in delaying or preventing recurrence and tumor growth progression of patients who have been previously treated by concomitant chemoradiotherapy (6 months) for high-grade glial tumors.
It will be an open-label trial of nutritional intervention for up to 1 year. An interim analysis of the data will be carried out to assess safety, compliance and efficacy of the diet. This will be reviewed by both SHS and the Clinical trial team.
- Conditions
- Malignant Tumors
- Being tested
- Nutritional support with Standard diet, Nutritional intervention with the Ketogenic diet
- Keywords
- Patients with malignant tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional support with Standard dietOther
Nutritional support with Standard diet
Nutritional intervention with the Ketogenic dietOther
Nutritional intervention with ketogenic diet. The Diet plan will be based on each patient individually according to his nutritional needs. Age, weight, activity levels, culture and food preferences are taken in consideration
| Study group | Role | What they receive |
|---|---|---|
| Standard diet: Nutritional support | Placebo comparator | Not described Receives: Other: Nutritional support with Standard diet |
| Nutritional intervention: Ketogenic diet. | Experimental | Not described Receives: Other: Nutritional intervention with the Ketogenic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the effect of the ketogenic diet on tumor growth progression and longevity in patients with Malignant glioblastoma.
This will be done by comparing tumor size by repeated MRI studies (every 2 months)
Secondary outcomes (1)
Quality of life
Performance scale and quality of life evaluation (Karnofsky and EQ5D scale)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionMay 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant TumorsStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Nutricia Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092247
- Sponsor's protocol ID
- TASMC-09-NV-0056-CTIL
- Status last verified
- Feb 2010
- First submitted
- 15 Mar 2010
- Last updated
- 24 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ketogenic Diet on Malignant Tumors- Recurrence and Progress
- ClinicalTrials.gov ID
- NCT01092247
- Acronym / sponsor ID
- TASMC-09-NV-0056-CTIL
- Conditions
- Malignant Tumors
- Keywords
- Patients with malignant tumors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Nutricia Liverpool
- Study start
- Mar 2010
- Primary completion
- May 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 24 Mar 2010 (estimated)
- 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.
The aim of the study is, to study the efficacy of the ketogenic diet in delaying or preventing recurrence and tumor growth progression of patients who have been previously treated by concomitant chemoradiotherapy (6 months) for high-grade glial tumors.
It will be an open-label trial of nutritional intervention for up to 1 year. An interim analysis of the data will be carried out to assess safety, compliance and efficacy of the diet. This will be reviewed by both SHS and the Clinical trial team.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard diet: Nutritional support | Placebo comparator | Other: Nutritional support with Standard diet |
| Nutritional intervention: Ketogenic diet. | Experimental | Other: Nutritional intervention with the Ketogenic diet |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Consenting adults aged ≥ 18 years.
- Recurrent or progressive high grade glioma after failure of at least one line of standard oncological treatment.
- Gliomatosis cerebri, including patients declining radiation treatment.
Key exclusion criteria (2 listed)
- Patients with malignant tumors who are receiving treatment at the time of the recruitment.
- Early termination - patients who will wish to stop their participation in the trial will discontinue the ketogenic diet and return to their usual diet.
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 |
|---|---|---|
| Nutritional support with Standard dietNutritional support with Standard diet | Other | Standard diet: Nutritional support |
| Nutritional intervention with the Ketogenic dietNutritional intervention with ketogenic diet. The Diet plan will be based on each patient individually according to his nutritional needs. Age, weight, activity levels, culture and food preferences are taken in consideration | Other | Nutritional intervention: Ketogenic diet. |
Primary outcome
To study the effect of the ketogenic diet on tumor growth progression and longevity in patients with Malignant glioblastoma.
This will be done by comparing tumor size by repeated MRI studies (every 2 months)
1 secondary outcome
Quality of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2010.
Related trials for Malignant Tumors
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
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.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional support with Standard diet and Nutritional intervention with the Ketogenic diet in people with Malignant Tumors, run by Tel-Aviv Sourasky Medical Center.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nachum Vaisman, Prof' (009-972-3-6974807, vaisman@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study the effect of the ketogenic diet on tumor growth progression and longevity in patients with Malignant glioblastoma.. 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 24 Mar 2010.