Ketogenic Diet Compliance in Patients Affected by Locally Advanced Rectal Cancer Patients Who Undergo to Radiotherapy — KOMPARC  

Rectal Cancer Clinical Trial

Official title: Ketogenic Diet Compliance in Patients Affected by Locally Advanced Rectal Cancer Patients Who Undergo to Radiotherapy: a Prospective, Randomized, Mono-centric Study

Status Not yet recruiting

Clinical Trial 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

Clinical Trial Description

Some days before the start of radiotherapy there will be the first visit in which patients will be enrolled and placed in one of the following two groups:

• The intervention group (KD) will be prescribed a ketogenic diet therapy plan characterized by the following composition: carbohydrates < 30g/day, 1.2g-1.5g protein/kg/day and lipids > 65%.

• The control group (SD) will be prescribed a nutrition plan based on the Mediterranean diet model according to ESPEN guidelines (carbohydrates 45-55%, protein 15-20% and lipids 30-35%) There will then be two additional follow-ups for patients: one during the period of therapy and one at the end of therapy.

Compliance with diet therapy treatment (SD vs. KD) will be assessed by analysis of a food diary that the patient will be asked to complete.

During follow-ups it will be assessed:

• BMI and body composition (by bioimpedance analysis)

• Muscle strength and physical performance (by hand grip test and sit-to-stand test) Compliance with and toxicity of radiochemotherapy treatment will be assessed at the radiochemotherapy visits (3 visits during treatment) ;

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

• NCT number: NCT05938322
• Study type: Interventional
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Maria Cristina Mele, MD
• Phone: 00390630156772
• Email: mariacristina.mele@unicatt.it
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2023
• Completion date: July 2025