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Recruiting NCT05938322

Ketogenic Diet Compliance in Patients Undergoing Radiotherapy for Pelvic Cancers

Trial Parameters

Condition Rectal Cancer
Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Type INTERVENTIONAL
Phase N/A
Enrollment 194
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-06-10
Completion 2026-12
Interventions
Ketogenic DietStandard Diet

Brief 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 Criteria

Inclusion Criteria: * Histologic confirmation of rectal adenocarcinoma * Locally advanced rectal cancer * Patients undergoing neoadjuvant radiotherapy treatment * Signature of informed consent to the processing of personal data Exclusion Criteria: * Severely malnourished patients according to GLIM (Global Leadership Initiative on Malnutrition) criteria * Patients treated for palliative purposes * Patients with metastatic disease * Diabetes mellitus * Pregnancy or lactation * Significant food allergies that would make the person unable to consume the food provided * Refusal to participate in the proposed clinical trial

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