Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Adenocarcinoma

Weight Loss

Body Weight

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Carbohydrate restricted diet and phone counseling with dietitian. After 6 months, patients will crossover to a non-restricted diet.

Non-restricted diet and after 6 months, patients will crossover to a carbohydrate restricted diet and phone counseling with dietitian

Carbohydrate restricted diet

Non-restricted diet

Phone counseling with dietitian

Stephen Freedland, MD

This phase 2 waitlist-controlled, randomized trial is designed to compare the difference in proliferative index (Ki67) between carbohydrate restricted diet and usual care over a 6 month period in men with prostate cancer who have been placed on Active Surveillance. Eligible patients include men over 18 years old, BMI \>25, with their most recently performed biopsy pathologically confirming prostate adenocarcinoma who have been placed on AS. Arms of the trial will be randomized 1:1 in a crossover approach, with Arm A receiving a carb restricted diet over 6 months then SOC and Arm B receiving the waitlist control arm (i.e. SOC then allowed to go on diet after 6 months). Ki67 will be performed on tissue from the most recent biopsy at the beginning of the study and again on tissue obtained in the 6 month SOC biopsy. Every patient will be on the study for 12 months, and the study will continue for approximately 3.5 years.

Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance

Carbohydrate and Prostate Study 3: Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance

Proliferative index is measured by Ki67/apoptosis rate

AUA intermediate risk is PSA \> 10ng/ml or grade group ≥ 2 or clinical stage ≥ T2b

Cedars-Sinai Medical Center

Director, Center for Integrated Research in Cancer and Lifestyle; Co-Director, Cancer Genetics and Prevention Program; Professor, Surgery

Nervous System Diseases

Rare Diseases

Glioma

Neoplasm Metastasis

Brain Neoplasms

Neoplastic Processes

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Neuroepithelioma

Patients will adhere to a classic ketogenic diet for a period of 3 months with a possible extension depending on their compliance on the diet.

Patients/families will meet with the study dietician to discuss the CKD, ask questions, and plan clinic visits. Training will take place about diet, meal planning, and ketones/glucose monitoring. The dietitian will follow the patient throughout treatment. Patients will measure their urine ketosis with urine test strips and capillary ketones with blood ketone meters daily, and they will complete records from the start till the end of the study. Finally, they will meet with the dietitian at follow-up visits and on an as-needed basis.

Arezina N. Kasti, RD

Evangelos K. Papadopoulos, MD

Efstathios Boviatsis, MD

The survival interval of patients with gliomas ranges between 12 to 15 months. Recent findings revealed that dietary interventions to reduce glucose and glycolytic pathways could have a therapeutic effect. Ketosis can be an effective therapy to extend the survival of patients with gliomas.

Gliomas are invasive and aggressive tumors, which derive from glial or stem cells, and after neoplastic transformation, acquire glial cell characteristics. Treatment of high-grade gliomas includes measures to relieve symptoms and eliminate or control the tumor. Surgery, radiation, and chemotherapy are the most common options. Recent findings revealed that dietary interventions to reduce glucose and glycolytic pathways could have a therapeutic effect. CKD is a restrictive therapeutic diet consisting of a 4:1 ratio of fat-to-CHO and protein. Fat provides up to 90% of the caloric intake, while overall CHO intake is less than 50 g/day. CKD reducing blood glucose levels and increasing ketone body levels stimulates biochemical changes to achieve systemic ketosis. Though, evidence for CKD in clinical practice is still limited. This study focuses on the classic ketogenic diet (CKD), adjusted for each patient's energy needs by dieticians to achieve ketosis. The primary outcome is to assess the efficacy of CKD to extend the survival of patients with high-grade gliomas and brain metastases. Historical controls will be used to compare the outcome measurements.

A Ketogenic Diet as a Complementary Treatment on Patients With High-grade Gliomas and Brain Metastases

A "Classic" Ketogenic Diet as a Complementary Therapeutic Management on Patients With High-grade Gliomas and Brain Metastases.

MRI (Magnetic Resonance Imaging) will be used to measure changes in tumor size (cm\^2)

50-item FACT-Br (Functional Assessment of Cancer Therapy - Brain) is a self-report and interview when applicable questionnaire used to assess quality of life, which includes domains such as Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, Brain Cancer Subscale. Each of them is rated based on the Likert scale from 1 to 5.

The scoring is assigned by a health professional based on the hierarchical scale: 100=normal, no evidence of disease, while 10=death. Intermediate or decimal scores can be assigned.

Attikon Hospital

Registered Dietitian, MSc, PhDc

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance	NCT03679260	Prostate Cancer	Carbohydrate re... Non-restricted ... Phone counselin...	18 Years -	Cedars-Sinai Medical Center
A Ketogenic Diet as a Complementary Treatment on Patients With High-grade Gliomas and Brain Metastases	NCT05564949	Brain Cancer	CKD	18 Years - 80 Years	Attikon Hospital
A Ketogenic Diet as a Complementary Treatment on Patients With High-grade Gliomas and Brain Metastases	NCT05564949	Brain Cancer	CKD	18 Years - 80 Years	Attikon Hospital

Spots Global Cancer Trial Database for ketogenic

Every month we try and update this database with for ketogenic 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 ketogenic

Every month we try and update this database with for ketogenic 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 ketogenic 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.