Clinical trial · Interventional
Ketogenic Diet Compliance in Patients Undergoing Radiotherapy for Pelvic Cancers
Compliance With Ketogenic Diet in Patients Undergoing Radiotherapy for Pelvic Cancers: a Prospective, Randomized, Mono-centric Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ketogenic Diet | Other | — | UNRESOLVED |
| Standard Diet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ketogenic Diet
- description
- In the group of intervention is prescribed a ketogenic diet plan.
- interventionNames
- Other: Ketogenic Diet
- type
- ACTIVE_COMPARATOR
- label
- Standard Diet
- description
- The control group (SD) will follow the Mediterranean diet pattern based on ESPEN (European Society of Parenteral and Enteral Nutrition) guidelines
- interventionNames
- Other: Standard Diet
Primary outcomes (1)
- measure
- Adherence to the ketogenic diet
- timeFrame
- 2 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available