Ketogenic Diet Compliance in Patients Affected by Locally Advanced Rectal Cancer Patients Who Undergo to Radiotherapy

Study Overview
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Brief Summary
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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
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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)

Official Title
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Ketogenic Diet Compliance in Patients Affected by Locally Advanced Rectal Cancer Patients Who Undergo to Radiotherapy: a Prospective, Randomized, Mono-centric Study

Conditions
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Rectal Cancer

Intervention / Treatment
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* Other: Ketogenic Diet
* Other: Standard Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketogenic Diet<br>In the group of intervention is prescribed a ketogenic diet plan. | Other: Ketogenic Diet<br>* 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)<br>|
| Active Comparator: Standard Diet<br>The control group (SD) will follow the Mediterranean diet pattern based on ESPEN (European Society of Parenteral and Enteral Nutrition) guidelines | Other: Standard Diet<br>* The control group (SD) will follow the Mediterranean diet pattern based on ESPEN guidelines (carbohydrates 45-55%, protein 15-20% and lipids 30-35%).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to the ketogenic diet | The primary objective is to assess the adherence to the diet therapy treatment plan (SD vs. KD). It will be verified through a food diary that will be given to the patient during the first visit. The patients will fill out the questionnaire and return it at future visits. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of fat mass (FM) in the group of patients on ketogenic diet (KD) compared with the control group | The assessment will be carried out through the use of an impedance analysis (BIA) | 2 months | 
| Evaluation of maintenance of metabolically active mass (BCM) in the group of patients on ketogenic diet (KD) compared with the control group | The assessment will be carried out through the use of an impedance analysis (BIA) | 2 months | 
| Investigate the impact of BCM maintenance on metabolic, inflammatory, hematologic and endocrine response | The assessment will be carried out through blood test analysis | 2 months | 
| Evaluation of the correlation between ketogenic diet (KD) and metabolic, inflammatory, hematologic and endocrine response | The assessment will be carried out through blood test analysis | 2 months | 
| Evaluation of the tolerability to the treatment | Radiotherapy interruptions will be evaluated | 2 months | 
| Evaluation of the response to the treatment | The assessment will be carried out through pelvic MRI analysis, clinical evaluation, and pathological response | 2 months | 
| Investigate indices of quality of life | Investigating patients' quality of life through questionnaires administered at the beginning and at the end of treatments. The questionnaires used are EORT ( European Organisation for Research and Treatment of Cancer) QLQ (quality of life questionnaire)-30, QLQ - CR29 and CAX-24 (cancer cachexia-specific questionnaire), and PRT-20 (quality of life questionnaire for proctitis). | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectal Cancer, Ketogenic Diet