Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT05938322

Ketogenic Diet Compliance in Patients Undergoing Radiotherapy for Pelvic Cancers

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-09-05

194

Participants Needed

1

Research Sites

181 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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

CONDITIONS

Official Title

Ketogenic Diet Compliance in Patients Undergoing Radiotherapy for Pelvic Cancers

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologic confirmation of rectal adenocarcinoma
  • Locally advanced rectal cancer
  • Patients undergoing neoadjuvant radiotherapy treatment
  • Signature of informed consent to the processing of personal data
Not Eligible

You will not qualify if you...

  • Severely malnourished patients according to GLIM 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Rome, Italy

Actively Recruiting

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Research Team

M

Maria Cristina Mele, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Ketogenic Diet Compliance in Patients Undergoing Radiotherapy for Pelvic Cancers | DecenTrialz