MedTrace Logo

Ketogenic Diet Compliance in Patients Undergoing Radiotherapy for Pelvic Cancers

NCT05938322 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2025-09-05

No results posted yet for this study

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

Interventions

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)

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%).

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Maria Cristina Mele · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-10
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05938322 on ClinicalTrials.gov