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Patients with locally advanced non-metastatic adenocarcinoma of the rectum undergoing chemoradiation therapy will be assigned to 2 groups:
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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketogenic Diet | Experimental | In the group of intervention is prescribed a ketogenic diet plan. |
|
| Standard Diet | Active Comparator | The control group (SD) will follow the Mediterranean diet pattern based on ESPEN (European Society of Parenteral and Enteral Nutrition) guidelines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketogenic Diet | Other | 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) |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Cristina Mele, MD | Contact | 00390630156772 | mariacristina.mele@unicatt.it |
| Name | Affiliation | Role |
|---|---|---|
| Maria Cristina Mele | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli, IRCCS | Recruiting | Rome | Italy |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D055423 | Diet, Ketogenic |
| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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|
| Standard Diet | Other | The control group (SD) will follow the Mediterranean diet pattern based on ESPEN guidelines (carbohydrates 45-55%, protein 15-20% and lipids 30-35%). |
|
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 |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |