Ketogenic Diet Compliance in Patients Undergoing Radiotherapy for Pelvic Cancers

Condition(s) studied

Investigational drug(s) / intervention(s)

Ketogenic 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)

Standard 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%).

Study 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

Primary outcome measure(s)

• Adherence to the ketogenic diet — 2 months
  The primary objective is to assess the adherence to the diet therapy treatment plan (SD vs. KD). It will be verified through a food diary that will be given to the patient during the first visit. The patients will fill out the questionnaire and return it at future visits.

Trial sites (1)

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