Keto Diet vs Standard Cancer Diet for Glioblastoma
Recruiting in Palo Alto (17 mi)
+5 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Cedars-Sinai Medical Center
Disqualifiers: Recurrent glioblastoma, Genetic disorders, Pregnancy, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, it does mention that off-label therapy use is permitted, which might suggest some flexibility. It's best to discuss your specific medications with the trial coordinators.
What data supports the effectiveness of the ketogenic diet treatment for glioblastoma?
Research suggests that ketogenic diets may help reduce tumor growth and improve survival in glioma patients by lowering blood sugar levels. Some studies have shown beneficial effects on survival and progression-free survival, but more high-quality research is needed to confirm these findings.
12345Is the ketogenic diet safe for humans, particularly in cancer treatment?
The ketogenic diet (KD) has been generally well-tolerated in clinical studies, with only minor side effects reported, such as constipation. Adverse events attributed to the diet were rare and mostly minor, except for one severe event. Overall, KD appears safe for use in humans, including those undergoing cancer treatment, but more high-quality studies are needed to confirm these findings.
14567How is the ketogenic diet treatment unique for glioblastoma?
The ketogenic diet is unique for glioblastoma because it aims to starve cancer cells by reducing blood glucose levels, which these cells rely on for growth, while providing energy through ketones that normal brain cells can use more efficiently.
13478Eligibility Criteria
This trial is for adults over 18 with newly diagnosed glioblastoma who haven't started chemotherapy or radiation. They must be able to perform daily activities well (KPS ≥ 70), read and understand English or Spanish, and commit to the study's requirements. Excluded are those with recurrent glioblastoma, certain genetic disorders, high steroid needs, pregnancy/nursing status, other experimental therapies, comorbidities that limit participation as per investigator's opinion, electronic medical implants unsafe for MRIs (with some exceptions), BMI < 21kg/m2 unless deemed safe by the investigator.Inclusion Criteria
Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
I am 18 years old or older.
I was diagnosed with glioblastoma less than 2 months ago.
+3 more
Exclusion Criteria
I have a genetic disorder that affects how my body processes fats.
I cannot reduce my steroid dose below 8mg of dexamethasone or its equivalent per day.
My glioblastoma has come back after treatment.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants are randomized to receive either a Keto Diet or Standard Anti-Cancer Diet for 18 weeks, alongside standard of care treatment for glioblastoma
18 weeks
Regular visits for diet monitoring and standard care
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of quality of life, cognitive performance, and physical activity
18 weeks
Long-term Follow-up
Participants' overall survival is tracked for up to 18 months from baseline
18 months
Participant Groups
The study compares two diets in patients with glioblastoma: a Keto Diet versus a Standard Anti-Cancer Diet. Each participant will also receive standard cancer treatments alongside their assigned diet. The Keto Diet group will have an 18-week intervention monitored by research dietitians through daily ketone and glucose level checks.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Keto-DietExperimental Treatment1 Intervention
Intensive 18-week Keto Diet intervention.
Group II: Standard Anti-Cancer DietPlacebo Group1 Intervention
Standard Anti-Cancer Diet with Dietitian support
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Baylor Scott & White HealthTemple, TX
Cedars-Sinai Medical CenterLos Angeles, CA
Duke UniversityDurham, NC
Pacific Neuroscience Institute / Saint John's Cancer InstituteSanta Monica, CA
More Trial Locations
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Who Is Running the Clinical Trial?
Cedars-Sinai Medical CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Methodological Approaches to Ketogenic Dietary Treatments in Glioma Patients from a Nutritional Point of View. [2022]Ketogenic diets (KD) have received increasing interest in neuro-oncology based on their ability to inhibit glioma growth In Vitro and their established role in medically refractory seizures. This review analyses the methodological aspects of KD treatment alongside standard care for patients with gliomas from a nutritional point of view. A literature search was performed in March 2022 searching PubMed and Scopus. We identified 13 articles including 187 patients with a histological-new or recurrent-diagnosis of glioma and treated by KD during the course of the disease. Dietary treatments were categorized as the classical ketogenic diet (CKD), the Modified Atkins diet (MAD), and the medium-chain triglyceride (MCT) diet. We identified a large variation in dietary characteristics regarding restriction of carbohydrates, ketogenic ratio, and additional dietary support. This striking heterogenicity in the methodological approaches of KD treatments made it problematic to compare effects between the included studies. Therefore, a standardized definition of KD for patients with glioma and a consensus on methodological implementation is needed. It would also be desirable to further investigate to what extent KD treatment can be optimized to secure optimal nutrient status and patient satisfaction.
The role of ketogenic diets in the therapeutic management of adult and paediatric gliomas: a systematic review. [2019]We performed a systematic review of the evidence for effectiveness and acceptability of different ketogenic diets (KDs) in the therapeutic management of gliomas.
Treatment of malignant gliomas with ketogenic or caloric restricted diets: A systematic review of preclinical and early clinical studies. [2022]Patients with malignant gliomas have a poor prognosis. Diets that lower blood glucose, such as ketogenic or caloric restricted diets (KCRDs), are hypothesized to reduce tumor growth and improve survival. In this systematic review, we summarize preclinical and clinical data on KCRDs in gliomas.
Ketogenic diets in medical oncology: a systematic review with focus on clinical outcomes. [2020]Preclinical data provide evidence for synergism between ketogenic diets (KDs) and other oncological therapies. The aim of this systematic review was to summarize data from clinical studies that have tested KDs along with other treatments used within medical oncology. The PubMed database was searched using the key words "ketogenic" AND ("cancer" OR "glioblastoma"). A secondary search was conducted by screening the reference lists of relevant articles on this topic. Relevant studies for this review were defined as studies in which KDs were used complementary to surgery, radio-, chemo-, or targeted therapy and at least one of the following four outcomes were reported: (i) Overall survival (OS); (ii) progression-free survival (PFS); (iii) local control rate; (iv) body composition changes. Twelve papers reporting on 13 clinical studies were identified. Nine studies were prospective and six had a control group, but only two were randomized. KD prescription varied widely between studies and was described only rudimentarily in most papers. Adverse events attributed to the diet were rare and only minor (grade 1-2) except for one possibly diet-related grade 4 event. Studies reporting body composition changes found beneficial effects of KDs in both overweight and frail patient populations. Beneficial effects of KDs on OS and/or PFS were found in four studies including one randomized controlled trial. Studies in high-grade glioma patients were not sufficiently powered to prove efficacy. Evidence for beneficial effects of KDs during cancer therapy is accumulating, but more high-quality studies are needed to assess the overall strength of evidence.
The Modified Ketogenic Diet in Adults with Glioblastoma: An Evaluation of Feasibility and Deliverability within the National Health Service. [2022]There is an increasing interest in the use of the ketogenic diet (KD) as an adjuvant therapy for glioma patients. We assessed the tolerability and feasibility of a modified ketogenic diet (MKD) in patients with glioma, along with willingness of patients to participate in future randomized controlled trials. The study was undertaken in two parts; a patient questionnaire and evaluation of the diet. One hundred and seventy-two questionnaires were completed; 69% (n = 119) of the population reported MKD should be offered to patients with glioma and 73% (n = 125) would be willing to try MKD for 3 months. Six male patients with high grade gliomas tried the diet; 4 completed the 3-month feasibility period. Ketosis was achieved in all patients. The only gastrointestinal side effect was constipation (n = 2). Minimal changes were observed in weight, body mass index, fat mass and cholesterol profiles. MKD was well tolerated, with few side effects and is deliverable within a financially viable, NHS service. There is a high level of interest in the diet within the glioma patient community to ensure adequate recruitment for a clinical trial. Further studies are required to demonstrate efficacy and patient benefit before implementing a service.
Ketogenic diets as an adjuvant therapy in glioblastoma (the KEATING trial): study protocol for a randomised pilot study. [2022]Glioblastoma is the commonest form of malignant brain tumour in adults, affecting 2-3 people per 100,000 per year. Despite current treatment options including surgical resection, radiotherapy and temozolomide chemotherapy, overall survival at 2 years is approximately 27%, with a median survival of 12-14 months. The ketogenic diet (KD) is postulated to work by simulating the metabolic response to fasting by promoting the utilisation of ketones as a primary energy source, and depriving the glycolytic pathways utilised by malignant glioma cells for growth. At present, there is no consensus as to which KD is preferable, with previous case series using different KDs, at different points in the treatment pathway. The aim of this randomised pilot study is to investigate protocol feasibility, tolerability and the impact on patient health and quality of life of two different KDs within an NHS setting. The results of this pilot study will inform which KD will be most deliverable and adhered to by patients in order to test for effectiveness in future trials.
Treatment of glioma patients with ketogenic diets: report of two cases treated with an IRB-approved energy-restricted ketogenic diet protocol and review of the literature. [2023]Based on the hypothesis that cancer cells may not be able to metabolize ketones as efficiently as normal brain cells, the ketogenic diet (KD) has been proposed as a complementary or alternative therapy for treatment of malignant gliomas.
Effects of the Ketogenic Diet in the Treatment of Gliomas: A Systematic Review. [2022]The ketogenic diet (KD) is a restrictive therapeutic diet, distinguished by being hyperlipidic, normoproteic, and hypoglucidic. This diet simulates biochemical changes related to fasting periods to achieve systemic ketosis. The metabolic particularities of glioma tumors motivated the rise in investigations and nutritional strategies, such as KD, to modulate the glycemic response as a treatment. This systematic review followed the PRISMA recommendations and was published in PROSPERO, with the identification CRD42021264173. The databases used were EMBASE, PubMed/Medline, Scopus, and Web of Science, and the studies were analyzed using the web-based application Rayyan. To analyze the risk of bias, Cochrane RevMan 5 software was used. For the analysis and treatment of statistical data, Microsoft® Excel® was used. A total of nine original articles were included. Data on survival, symptomology, and quality of life were collected. Mean overall survival was 15.9 months. Constipation and fatigue were the most reported symptoms. In 44.4% of the studies, an improvement in the quality of life was found. The KD is supported by most published studies as an effective therapy in the treatment of malignant gliomas due to its positive effects on patient survival. It was not possible to conclude the effectiveness of KD on quality of life.