Ketogenic Diet Compliance in Patients Undergoing Radiotherapy for Pelvic Cancers
Recruiting · NCT05938322 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Ketogenic DietStandard Diet
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
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Fondazione Policlinico Universitario Agostino Gemelli, IRCCS - Rome, Italy