RecruitingNot ApplicableNCT05938322

Ketogenic Diet Compliance in Patients Undergoing Radiotherapy for Pelvic Cancers

Compliance With Ketogenic Diet in Patients Undergoing Radiotherapy for Pelvic Cancers: a Prospective, Randomized, Mono-centric Study


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

194 participants

Start Date

Jun 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Patients with locally advanced non-metastatic adenocarcinoma of the rectum undergoing chemoradiation therapy will be assigned to 2 groups: * the intervention group will be prescribed an individualized ketogenic eating plan to be followed throughout the treatment period * the control group will be prescribed a diet therapy plan treatment following the international guidelines of clinical nutrition, also to be followed during treatment


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether patients with rectal cancer can follow a ketogenic diet (a high-fat, very low-carbohydrate diet) while undergoing radiation therapy, and whether this diet helps improve treatment outcomes. **You may be eligible if...** - You have been diagnosed with locally advanced rectal adenocarcinoma (a type of rectal cancer confirmed by biopsy) - You are scheduled to receive radiation therapy before surgery (neoadjuvant radiotherapy) - You have agreed to participate and provided consent for data use **You may NOT be eligible if...** - You are severely malnourished - You have medical conditions that make a ketogenic diet unsafe (such as liver or kidney disease, certain metabolic disorders) - You are unable or unwilling to follow a strict dietary plan Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERKetogenic Diet

In the group of intervention is prescribed a ketogenic diet plan characterized by the following composition: carbohydrates \< 30g/day, 1.2g-1.5g protein/kg/day and lipids \> 65%. This diet will be followed during the period of treatment with chemo-radiotherapy (5 weeks)

OTHERStandard Diet

The control group (SD) will follow the Mediterranean diet pattern based on ESPEN guidelines (carbohydrates 45-55%, protein 15-20% and lipids 30-35%).


Locations(1)

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Rome, Italy

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NCT05938322


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