Ketogenic Diet Compliance in Patients Undergoing Radiotherapy for Pelvic Cancers

NCT ID: NCT05938322

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-10
• Study Completion Date: 2027-12-31

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)

Conditions

Rectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Ketogenic Diet

In the group of intervention is prescribed a ketogenic diet plan.

Group Type: EXPERIMENTAL

Ketogenic Diet

Intervention Type: OTHER

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 (European Society of Parenteral and Enteral Nutrition) guidelines

Group Type: ACTIVE_COMPARATOR

Standard Diet

Intervention Type: OTHER

The control group (SD) will follow the Mediterranean diet pattern based on ESPEN guidelines (carbohydrates 45-55%, protein 15-20% and lipids 30-35%).

Interventions

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)

Intervention Type: OTHER

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%).

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Mele Maria Cristina

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Cristina Mele

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Rome, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Maria Cristina Mele, MD

Role: CONTACT

mariacristina.mele@unicatt.it

00390630156772

Other Identifiers

5812

Identifier Type: -

Identifier Source: org_study_id