Neoplasms

All Conditions

Rare Diseases

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Temozolomide

Antineoplastic Agents, Alkylating

Alkylating Agents

Ketogenic diet in combination with standard-of-care radiation and standard-of-care temozolomide

A 4-month ketogenic diet will be supervised and monitored by the study investigators. Study dietitians will create personalized meal plans for each patient with the goal of achieving and maintaining metabolic ketosis.

Ketogenic Diet

Patients will receive standard-of-care radiation. Radiation is not protocol directed.

Standard-of-care radiation

Patients will receive standard-of-care temozolomide. Temozolomide is not protocol directed.

Standard-of-care Temozolomide

Jethro Hu, MD

Enrolled subjects will be placed on a 16-week ketogenic diet (subject specific as prescribed by RD) while receiving standard of care cancer treatment (Radiation + Temozolomide). Study dietitians will create personalized meal plans for each patient with the goal of achieving and maintaining protocol defined metabolic ketosis. Subjects will be monitored for safety, nutrition, quality of life, and standard of care tumor assessments over the course of the study.

Enrolled subjects will be placed on a 16-week ketogenic diet (subject specific as prescribed by RD) while receiving standard of care cancer treatment (Radiation + Temozolomide). Study dietitians will place patients on a strict and controlled diet that manages daily macronutrient breakdown and increases the ratio of dietary fat relative to protein and carbohydrate consumption. Dietitians will provide guidance and teaching of the diet, as well as, monitoring and diet adjustment to ensure metabolic ketosis. Dietitians and study physicians (and their staff) will monitor subjects for safety, nutrition, quality of life, and standard of care tumor assessments over the course of the study.

Ketogenic Diet in Combination With Standard-of-care Radiation and Temozolomide for Patients With Glioblastoma

IIT2016-17-HU-KETORADTMZ: A Phase 1 Study of a 4-month Ketogenic Diet in Combination With Standard-of-care Radiation and Temozolomide for Patients With Newly/Recently Diagnosed Glioblastoma

Proportion of participants experiencing a 10% decrease in weight or body mass index AND have a BMI \<18.5 within one month from initiation of the ketogenic diet.

Number of related adverse events based on CTCAE v.5.

Proportion of enrolled patients able to maintain blood ketone levels \>0.3 mM for over 50% of days on study starting 2 weeks after initiation of the ketogenic diet.

Time (in months) from initiation of the ketogenic diet to date of death

Time (in months) from baseline to progressive disease over study duration (estimated 4 months)

- measured by RANO criteria (standard of care brain MRI)

Mean change in overall Quality of Life from baseline to two months.

-Quality of Life measured using EORTC QLQ-C30 global score

Mean change in overall Quality of Life from baseline to four months.

-Quality of Life measured using EORTC QLQ-C30 global score

Mean change in cognitive function from initiation of ketogenic diet to four months.

-measured using Hopkins Verbal learning Test-Revised

Mean change in cognitive function from initiation of ketogenic diet to four months.

-measured using Trail Making Test

Mean change in cognitive function from initiation of ketogenic diet to four months.

-measured using Controlled Word Association Test

Mean change in cognitive function from initiation of ketogenic diet to four months.

-measured using Montreal Cognitive Assessment

Jethro Hu

Principal Investigator, Faculty

Digestive System Diseases

Gland and Hormone Related Diseases

Adenocarcinoma

Pancreatic Neoplasms

Carcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

Ketogenic diet plus nab-paclitaxel 125 mg/m2, cisplatin 25 mg/m2, and gemcitabine 1000 mg/m2 all administered intravenously (IV) on Days 1 and 8 every 21 days.

Non-ketogenic diet plus nab-paclitaxel 125 mg/m2, cisplatin 25 mg/m2, and gemcitabine 1000 mg/m2 all administered intravenously (IV) on Days 1 and 8 every 21 days.

Ketogenic diet (KD) will consist of macros: dietary carbohydrates restricted to \< 30 g/day; daily protein intake will be targeted to 1.5 g/kg/day (targeted to ideal body weight).

Vicki L Bauernschub, BSN RN

This study will evaluate the effects of the ketogenic diet in patients with metastatic pancreatic cancer while receiving chemotherapy.

A randomized, phase II trial designed to evaluate the progression free survival in patients with metastatic pancreatic cancer on triplet therapy (nab-paclitaxel + gemcitabine + cisplatin) while on ketogenic diet or non-ketogenic diet. This study also aims to compare the changes in serum metabolites and quality of life between the two arms.

Ketogenic diet with standard of care chemotherapy versus non-ketogenic diet with standard of care chemotherapy

Study Evaluating the Ketogenic Diet in Patients With Metastatic Pancreatic Cancer

Randomized Phase II Trial of Two Different Nutritional Approaches for Patients Receiving Treatment for Their Advanced Pancreatic Cancer

Progression-free survival (PFS) is defined as the time from randomization to first documentation of objective tumor progression or to death due to any cause.

To compare the number of complete responses/partial responses as defined by CT scan using the Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1) and CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) down to normal limits (from at least \> 2X ULN).

(Partial Response + Complete Response + Stable Disease for at least 9 weeks)

Change in CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9)

Rates of normalization of CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9)

To compare the average weight (kg), using BMI calculation (BMI = weight (kg) / height (m2))

Higher scores in the quality of life on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire QLC-C30 (EORTC QLQ-C30) assessment may show a better outcome.

Translational Genomics Research Institute

Translational Drug Development

Blood and Lymph Conditions

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Lymphoma

Lymphoma, Follicular

Endometrial Neoplasms

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Lymphosarcoma

Follicular Lymphoma

The lymphoma study group will enroll 23 patients with FL.

In cycle 1, patients will first start ketogenic diet for 7 days (Day -6 to Day 0). Only patients who demonstrate compliance and tolerance with the ketogenic diet for all 7 days, as confirmed by pertinent blood and urine tests, will be allowed to continue the study and treatment using copanlisib and the ketogenic diet starting on Day 1. In cycle 2 and beyond, patients will start the ketogenic diet and copanlisib on day 1.

The solid tumor group will enroll 19 patients with EC.

In cycle 1, patients will first start ketogenic diet for 7 days (Day -6 to Day 0). Only patients who demonstrate compliance and tolerance with the ketogenic diet for all 7 days, as confirmed by pertinent blood and urine tests, will be allowed to continue the study and treatment using copanlisib and the ketogenic diet starting on Day 1. In cycle 2 and beyond, patients will start the ketogenic diet and copanlisib on day 1.

Copanlisib will be infused intravenously on days 1, 8, 15 of each cycle, over 1 hour, of 28-day cycles.

Copanlisib

In cycle 1, patients will first start the ketogenic diet for 7 days (Day -6 to Day 0).

Only the patients who demonstrate compliance and tolerance with the ketogenic diet, as confirmed by pertinent blood and urine tests and a diary of diet, will be allowed to continue the study and start copanlisib on Day 1. The ketogenic diet will continue daily throughout the treatment days.

In cycle 2 and beyond, patients will start the ketogenic diet and copanlisib on day 1.

The ketogenic diet will then continue daily throughout the treatment days.

Jennifer E. Amengual, MD

This is a multicenter, open label, pilot phase II study of the PI3K inhibitor copanlisib in combination with a ketogenic diet in the treatment of patients with one of the following malignancies: (a) relapsed or refractory (R/R) follicular lymphoma (FL), (b) R/R endometrial cancer (EC) with a documented activating mutation in PIK3CA or loss of phosphatase and tensin homolog (PTEN).

As the investigators recently reported ketogenic diet can suppress hyperinsulinemia associated with PI3K inhibitors, leading to potentiation of the anti-tumor effects of PI3K inhibitors. Copanlisib potently inhibits PI3Kα and PI3Kδ. It has been approved for the treatment of relapsed follicular lymphoma, based on ORR of 59% (84 of 142 patients). The CR rate in FL was 14%, and the median progression-free survival was 11.2 months. Copanlisib demonstrated encouraging clinical activity in marginal zone lymphoma (ORR 70% including 9% CR). While these results are clinically meaningful, FL and MZL inevitably develop resistance to copanlisib with time, even in those patients who initially respond to the therapy. Novel strategies to improve the efficacy of copanlisib in FL and MZL, by improving CR and PFS, may transform how to manage these incurable malignancies.

Study of Copanlisib and Ketogenic Diet

Pilot Phase II Study of the PI3K Inhibitor Copanlisib in Combination With a Ketogenic Diet in the Treatment of Patients With Relapsed or Refractory Follicular Lymphoma or Endometrial Cancer

ORR will be determined from the number of individuals with a complete response (CR) and number of individuals with a partial response (PR)

ORR will be determined from the number of individuals with a complete response (CR) and number of individuals with a partial response (PR).

Total # of patients who are compliant with the ketogenic diet.

Bayer

Columbia University

Principal Investigator, Assistant Professor of Medicine

Micronutrients

Trace Elements

Intensive 18-week Keto Diet intervention.

Standard Anti-Cancer Diet with Dietitian support

The experimental intervention includes a strict and controlled diet that manages daily macronutrient breakdown and increases the ratio of dietary fat relative to protein and carbohydrate consumption.

Keto Diet

Dietitian sessions will utilize the American Institute for Cancer Research Food resources and will reference foods low in fats such as fruits, vegetables and whole grains, providing key micronutrients and phytonutrients. Sessions will also focus on dietary support to help decrease any treatment related symptoms.

Standard Anti-Cancer Diet

Clinical Trial Recruitment Navigator

Stephen Freedland, MD

Gillian Gresham, PhD

Mourad Tighiouart, PhD

Sungyong You, PhD

LJ Amaral, MS, RD, CSO

Jeremy Rudnick, MD

John Yu, MD

Chirag Patil, MD

Ray Chu, MD

Nicholas Butowski, MD

Akanksha Sharma, MD

Katherine Peters, MD, PhD

Lin Pao-Hwa, PhD

Jen-Tsan Chi, MD, PhD

Ekokobe Fonkem, DO

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.

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

A Randomized Controlled Phase 2 Study of the Ketogenic Diet Versus Standard Dietary Guidance for Patients With Newly Diagnosed Glioblastoma in Combination With Standard-of-care Treatment

Will be calculated as the number of days from the date of patient registration to the date of death.

Measured by changes in the Functional Assessment of Cancer Therapy - Brain (FACT-BR) survey scores. Scores can range from 0- 200, the higher the score the better the quality of life.

Measured by changes in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) survey scores. Scores can range from 0- 160, the higher the score the better the quality of life.

Assessed with Magnetic resonance imaging (MRI) scan of the brain with and without gadolinium. MRI's will be reviewed and assessed for progression free survival via the modified Response Assessment in Neuro-Oncology Criteria.

Measured by changes in the Hopkins Verbal Test (HVLT-R) survey scores. Scores can range from 0-36, higher the scores the better the cognitive performance.

Measured by changes in the Trail Marking Test A/B survey scores. The longer the task takes to complete the lower the cognitive performance.

Measured by changes in the modified Godin leisure questionnaire survey scores. The more minutes per week spent in exercise the better the physical activity.

Measured by Fitbit data changes. The higher the step count the better the physical activity.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ketogenic Diet in Combination With Standard-of-care Radiation and Temozolomide for Patients With Glioblastoma	NCT03451799	GBM Glioblastoma	Ketogenic Diet Standard-of-car... Standard-of-car...	18 Years -	Cedars-Sinai Medical Center
Study Evaluating the Ketogenic Diet in Patients With Metastatic Pancreatic Cancer	NCT04631445	Metastatic Panc...	Ketogenic Diet	18 Years -	Translational Drug Development
Study of Copanlisib and Ketogenic Diet	NCT04750941	Follicular Lymp... Endometrial Can...	Copanlisib Ketogenic Diet	18 Years -	Columbia University
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	NCT05708352	Glioblastoma Mu...	Keto Diet Standard Anti-C...	18 Years -	Cedars-Sinai Medical Center

Spots Global Cancer Trial Database for keto diet

Every month we try and update this database with for keto diet cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for keto diet

Every month we try and update this database with for keto diet cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for keto diet cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.