Ketogenic Diet Compliance in Patients Undergoing Radiotherapy for Pelvic Cancers (KOMPARC)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Rectal Cancer

Treatments: Other: Ketogenic Diet; Other: Standard Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05938322

5812

Details and patient eligibility

About

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

Full 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)

Enrollment: 194 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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194 participants in 2 patient groups

Ketogenic Diet

Experimental group

Description:

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

Treatment:

Other: Ketogenic Diet

Standard Diet

Active Comparator group

Description:

The control group (SD) will follow the Mediterranean diet pattern based on ESPEN (European Society of Parenteral and Enteral Nutrition) guidelines

Treatment:

Other: Standard Diet