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IIT2022-06-HU-DIET2TREAT

A phase 2 study of the ketogenic diet vs standard anti-cancer diet guidance for patients with glioblastoma in combination with standard-of-care treatment
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT05708352
Keto Diet
Source : Importé depuis le centre
Recrutement partiellement ouvert
Dernière modification : 2025/02/17
Type de recherche

Interventionnel

Médicament expérimental

PHASE2


Population cible

Condition médicale (spécialité visée)

Donnée non disponible

Profil des participants

Sexe(s) des participants

ALL

Source : Importé depuis le centre

Critères de sélection

Critères d'inclusion

Inclusion Criteria:

* Adults 18 years or older
* Newly diagnosed glioblastoma (Within 2 months of initial diagnosis by histopathology)
* Not started standard of care chemotherapy and/or radiation therapy for glioblastoma
* Karnofsky Performance Status (KPS) ≥ 70
* Ability to read, write and understand either English OR Spanish
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

* Patients with recurrent glioblastoma
* Genetic disorders that affect lipid metabolism. Including but not limited to pyruvate carboxylase deficiency, porphyria, primary carnitine deficiency, carnitine palmitoyltransferase I or II deficiency, carnitine translocase deficiency, beta-oxidation defects
* Inability to wean steroids below 8mg dexamethasone / day or equivalent
* Body Mass Index (BMI) \< 21kg/m2, unless the site Principal Investigator deems safe
* Currently pregnant or nursing
* Patients receiving other experimental therapy Note: Off-label therapy use is permitted
* Comorbidities that in the opinion of the investigator limit the patient's ability to complete the study
* Food preferences incompatible with keto diet
* Using a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implants (removable hearing aids permitted), or other electronic medical equipment, unless the site Principal Investigator deems safe
* Inability to participant in standard of care MRIs

Source : Importé depuis le centre

Thérapie ou Intervention proposée

Cohortes
Nom Condition médicale Traitement État du recrutement
Keto-Diet Intensive 18-week Keto Diet intervention. Donnée non disponible
  • Inconnu
  • Standard Anti-Cancer Diet Standard Anti-Cancer Diet with Dietitian support Donnée non disponible
  • Inconnu
  • Keto-Diet
    État du recrutement
    unknown
    Standard Anti-Cancer Diet
    État du recrutement
    unknown
    Données à jour depuis : 17 février 2025

    Description de l'étude

    Résumé de l'étude

    This is a Phase 2, randomized two-armed, multi-site study of 170 patients with newly diagnosed glioblastoma multiforme. Patients will be randomized 1:1 to receive Keto Diet, or Standard Anti-Cancer Diet. All patients will receive standard of care treatment for their glioblastoma. The Keto Diet intervention will be for an 18-week period and conducted by trained research dietitians. Daily ketone and glucose levels will be recorded to monitor Keto Diet adherence.

    This two-armed randomized multi-site study aims to provide evidence to support the hypothesis that a Keto Diet vs. Standard Anti-Cancer Diet improves overall survival in newly diagnosed glioblastoma multiforme patients who receive standard of care treatment.

    Source : Importé depuis le centre

    Sites

    Centres participants


    Dernière modification : 17 février 2025
    Données à jour depuis : 19 fév.
    Origine des données : clinicaltrials.gov
    Référence clinicaltrials.gov: NCT05708352