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Spots Global Cancer Trial Database for Ketogenic Diet Compliance in Patients Affected by Locally Advanced Rectal Cancer Patients Who Undergo to Radiotherapy

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Trial Identification

Brief Title: Ketogenic Diet Compliance in Patients Affected by Locally Advanced Rectal Cancer Patients Who Undergo to Radiotherapy

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

Study ID: NCT05938322

Conditions

Rectal Cancer

Study Description

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

Detailed 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)

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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