Ketogenic Diet Compliance in Patients Undergoing Radiotherapy for Pelvic Cancers

NCT05938322 | Recruiting

• 1 other identifier: 5812
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

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

Conditions

Rectal Cancer

Keywords

Rectal Cancer; Ketogenic Diet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Assessment of fat mass (FM) in the group of patients on ketogenic diet (KD) compared with the control group

  2 months

• Evaluation of maintenance of metabolically active mass (BCM) in the group of patients on ketogenic diet (KD) compared with the control group

  2 months

• Investigate the impact of BCM maintenance on metabolic, inflammatory, hematologic and endocrine response

  2 months

• Evaluation of the correlation between ketogenic diet (KD) and metabolic, inflammatory, hematologic and endocrine response

  2 months

• Evaluation of the tolerability to the treatment

  2 months

Study Arms (2)

Ketogenic Diet

EXPERIMENTAL

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

Other: Ketogenic Diet

Standard Diet

ACTIVE COMPARATOR

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

Other: Standard Diet

Interventions

Ketogenic Diet 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)

Ketogenic Diet

Standard Diet 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%).

Standard Diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic confirmation of rectal adenocarcinoma
• Locally advanced rectal cancer
• Patients undergoing neoadjuvant radiotherapy treatment
• Signature of informed consent to the processing of personal data

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Rome, Italy

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Maria Cristina Mele

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Cristina Mele, MD

CONTACT

00390630156772; mariacristina.mele@unicatt.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: July 10, 2023
• Study Start: June 10, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)