Evidence map›Paper›PMID 40595067›Full record

ArticleScientific reports2025

A phase 1 safety and feasibility trial of a ketogenic diet plus standard of care for patients with recently diagnosed glioblastoma.

L J Amaral, Gillian Gresham, Sungjin Kim, Mourad Tighiouart, Thomas A Nelson, Amelia Welborn, Laura Lockshon, Brandon Noorvash, Jeremy D Rudnick, Scott A Irwin and 2 more

Abstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Efficacy and safety of ketogenic diet in glioblastoma: an updated systematic review and meta-analysis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

L J Amaral *Cedars-Sinai Cancer, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Gillian Gresham *Cedars-Sinai Cancer, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Sungjin KimBiostatistics and Bioinformatics Research Center, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Mourad TighiouartBiostatistics and Bioinformatics Research Center, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Thomas A NelsonDepartment of Neuro-Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Amelia WelbornDepartment of Health, University of California Los Angeles, Los Angeles, CA, USA.
Laura LockshonCenter for Digestive Health, Virginia Mason Medical Center, Seattle, WA, USA.
Brandon NoorvashCedars-Sinai Cancer, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Jeremy D RudnickCedars-Sinai Cancer, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Scott A IrwinCedars-Sinai Cancer, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Stephen J FreedlandCedars-Sinai Cancer, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Jethro HuCedars-Sinai Cancer, Cedars-Sinai Medical Center, Los Angeles, CA, USA. Jethro.Hu@cshs.org.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Despite great interest, there is limited clinical evidence to support the use of a ketogenic diet (KD) for cancer patients. We conducted a single-arm phase 1 trial of a KD among patients with recently diagnosed glioblastoma (GBM) receiving standard-of-care (SOC) treatment. Adults with GBM within 3 months of diagnosis followed a supervised 16-week intervention of a 3:1 KD (Fat(g): Carbohydrate + Protein(g)) plus SOC chemoradiation. The primary outcome was safety, evaluated by weekly assessments of weight and body mass index (BMI). Secondary outcomes included feasibility (pre-specified as > 50% of patients maintaining blood ketone levels > 0.3 mM over 50% of study days), progression-free survival (PFS), overall survival (OS), health-related quality-of-life, and cognitive function. Twice daily blood glucose and ketones, weight/BMI, physical activity, and sleep were assessed by remote monitoring. Seventeen patients were evaluable: 53% women, median age 55, median Karnofsky Performance Status 85. All subjects met the primary safety objective with no instances of excessive weight loss or related serious adverse events. Adherence was high: all 17 patients maintained nutritional ketosis (≥ 0.3 mM/dL) > 50% of study days. Median PFS and OS were 12.9 months and 29.4 months from KD initiation respectively. Quality of Life, symptom control, and cognitive function remained stable or improved, although these did not reach statistical significance. This phase 1 trial demonstrates that KD is safe and feasible for GBM patients receiving SOC, may improve outcomes, and provides a foundation for an NCI-funded multicenter randomized diet trial to assess efficacy that is currently underway.

Indexed as

Brain NeoplasmsDiet, KetogenicGlioblastomaAdultAgedFeasibility StudiesFemaleHumansMaleMiddle AgedQuality of LifeStandard of CareTreatment OutcomeCancer metabolismGlioblastomaKetogenic dietsKetosisPhysical activityQuality of lifeSupportive careWarburg effect

Identifiers

PMID40595067
PMCPMC12215994

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.