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

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

NCT ID: NCT05938322

Condition: Rectal Cancer

Conditions: Official terms:
Rectal Neoplasms

Conditions: Keywords:
Rectal Cancer
Ketogenic Diet

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Ketogenic Diet
Description: 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)
Arm group label: Ketogenic Diet

Intervention type: Other
Intervention name: Standard Diet
Description: The control group (SD) will follow the Mediterranean diet pattern based on ESPEN guidelines (carbohydrates 45-55%, protein 15-20% and lipids 30-35%).
Arm group label: Standard Diet

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)

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Start date: July 2023

Completion date: July 2025

Lead sponsor:
Agency: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class: Other

Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05938322