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Recruiting NCT05938322

Ketogenic Diet Compliance in Patients Undergoing Radiotherapy for Pelvic Cancers

No phase Interventional Rectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ketogenic Diet, Standard Diet.
Who it may be relevant to
Registry conditions: Rectal Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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)

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%).

Primary outcome measures

  • Adherence to the ketogenic diet [Time frame: 2 months]
Secondary outcome measures (7)
  • Assessment of fat mass (FM) in the group of patients on ketogenic diet (KD) compared with the control group [Time frame: 2 months]
  • Evaluation of maintenance of metabolically active mass (BCM) in the group of patients on ketogenic diet (KD) compared with the control group [Time frame: 2 months]
  • Investigate the impact of BCM maintenance on metabolic, inflammatory, hematologic and endocrine response [Time frame: 2 months]
  • Evaluation of the correlation between ketogenic diet (KD) and metabolic, inflammatory, hematologic and endocrine response [Time frame: 2 months]
  • Evaluation of the tolerability to the treatment [Time frame: 2 months]
  • Evaluation of the response to the treatment [Time frame: 2 months]
  • Investigate indices of quality of life [Time frame: 2 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Italy · 1 center
  • Fondazione Policlinico Universitario Agostino Gemelli, IRCCS — Rome

Identifiers

NCT: NCT05938322 · 5812

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗