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

Compliance With Ketogenic Diet in Patients Undergoing Radiotherapy for Pelvic Cancers: a Prospective, Randomized, Mono-centric Study

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

Study Overview

• Status: Recruiting
• Conditions: Rectal Cancer
• Intervention / Treatment: Other: Ketogenic Diet; Other: Standard Diet

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)

• Study Type: Interventional
• Enrollment (Estimated): 194
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Cristina Mele, MD; Phone Number: 00390630156772; Email: mariacristina.mele@unicatt.it

Study Locations

• Italy
  • Rome, Italy
    • Recruiting
    • Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketogenic Diet; In the group of intervention is prescribed a ketogenic diet plan.	Other: 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)
Active Comparator: Standard Diet; The control group (SD) will follow the Mediterranean diet pattern based on ESPEN (European Society of Parenteral and Enteral Nutrition) guidelines	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%).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to the ketogenic diet	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.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of fat mass (FM) in the group of patients on ketogenic diet (KD) compared with the control group	The assessment will be carried out through the use of an impedance analysis (BIA)	2 months
Evaluation of maintenance of metabolically active mass (BCM) in the group of patients on ketogenic diet (KD) compared with the control group	The assessment will be carried out through the use of an impedance analysis (BIA)	2 months
Investigate the impact of BCM maintenance on metabolic, inflammatory, hematologic and endocrine response	The assessment will be carried out through blood test analysis	2 months
Evaluation of the correlation between ketogenic diet (KD) and metabolic, inflammatory, hematologic and endocrine response	The assessment will be carried out through blood test analysis	2 months
Evaluation of the tolerability to the treatment	Radiotherapy interruptions will be evaluated	2 months
Evaluation of the response to the treatment	The assessment will be carried out through pelvic MRI analysis, clinical evaluation, and pathological response	2 months
Investigate indices of quality of life	Investigating patients' quality of life through questionnaires administered at the beginning and at the end of treatments. The questionnaires used are EORT ( European Organisation for Research and Treatment of Cancer) QLQ (quality of life questionnaire)-30, QLQ - CR29 and CAX-24 (cancer cachexia-specific questionnaire), and PRT-20 (quality of life questionnaire for proctitis).	2 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Maria Cristina Mele, Fondazione Policlinico Universitario A. gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Rectal Cancer; Ketogenic Diet
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Rectal Neoplasms; Therapeutics; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet Therapy; Nutrition Therapy; Diet; Diet, Carbohydrate-Restricted; Diet, Ketogenic
• Other Study ID Numbers: 5812

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No