Clinical trial · Interventional
The Effect of Ketogenic Diet on Malignant Tumors- Recurrence and Progress
NCT01092247CI-TRIAL-00003288unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Tumors | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nutritional intervention with the Ketogenic diet | Other | — | UNRESOLVED |
| Nutritional support with Standard diet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Standard diet: Nutritional support
- interventionNames
- Other: Nutritional support with Standard diet
- type
- EXPERIMENTAL
- label
- Nutritional intervention: Ketogenic diet.
- interventionNames
- Other: Nutritional intervention with the Ketogenic diet
Primary outcomes (1)
- measure
- To study the effect of the ketogenic diet on tumor growth progression and longevity in patients with Malignant glioblastoma.
- description
- This will be done by comparing tumor size by repeated MRI studies (every 2 months)
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion criteria: 1. Consenting adults aged ≥ 18 years. 2. Recurrent or progressive high grade glioma after failure of at least one line of standard oncological treatment. 3. Gliomatosis cerebri, including patients declining radiation treatment. Exclusion criteria: 1. Patients with malignant tumors who are receiving treatment at the time of the recruitment. 2. Early termination - patients who will wish to stop their participation in the trial will discontinue the ketogenic diet and return to their usual diet.
References
Publications (0)
Data not yet available
No reference posted for this study.