Impact of Early and Active Nutritional and Dietary Management grade3 or More Toxicities Induced by Chemotherapy and Targeted Therapies Administered to Patients as First Intention for Non Surgical Metastatic Colorectal Cancer (CHIMIODIET)
Metastatic Colorectal Cancer
About this trial
This is an interventional prevention trial for Metastatic Colorectal Cancer focused on measuring Active nutritional and dietary management, Metastatic colorectal cancer, Non surgical metastatic colorectal cancer
Eligibility Criteria
Inclusion Criteria:
- Over 18 years of age
- Patients with synchrone or metachronous CRC metastases without possible initial surgical outcome
- Patients covered by Social Security
- Patients willing to sign the proper consent forms
Exclusion Criteria:
- Severely malnourished patients according to the Authority for Health criteria : weight loss > 5% of base weight in less than one month or > 10% of base weight in less than six months and/or BMI < 18 or 21.5 in patients 70 years old or more, and/or serum albumin assay < 35 g/l.
- Patients receiving concomitant radiotherapy.
- Patients receiving or programmed to receive artificial nutrition (enteral or parenteral).
- Pregnant or breastfeeding women (a qualitative urine pregnancy test will be given to all women of child-bearing age).
- Patients incapable of understanding (foreign language, intellectual deficiencies, motor cortex deficiencies...) and/or applying the nutritional counselling (persons institutionalised in a rest home, retirement home, prison etc.).
- Patients with another sever debilitating disease likely to impact on nutritional status (cardiac, hepatic, or renal insufficiency etc.).
- Persons already participating in another clinical trial.
Sites / Locations
- Institut Sainte Catherine
- The Léon Bérard Cancer Centre
- Assistance Publique des hopitaux de Marseille
- The Val d'Aurelle Cancer Centre
- University Hospital, Montpellier
- The Antoine Lacassagne Cancer Centre
- The digestive oncology departement of the Archet Hospital of the Nice University Hospital Centre
- Hospital in Perpignan
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
I - Early and active nutritional support.
II - No nutritional support
During the initial consultation, the dietician will answer the questions of the patient and their family. Patients will be seen regularly in follow-up for weight measurement, serum albumin assay, a 1 or 3 day food record and an evaluation of appetite level. Nutritional counselling is then adjusted accordingly and:Balanced meals are continued if weight is stable and appetite is undiminished.Protein and energy fortification is recommended if weight loss is observed or if food intake decreases between 2 consultations leading to total food intake of less than 50% of required food intake. When a patient presents with signs of malnutrition according to the criteria set out by the Authority for Health, oral nutritional support (ONS) is set up, in agreement with the department head. Two 200ml bottles of Fortimel Extra are to be taken every day. If this ONS strategy is insufficient to improve the patient's nutritional status, artificial nutrition should be discussed.
Should malnutrition develop in a group II patient, ONS will be ordered. It will consist of two 200ml Fortimel Extra* bottles per day in addition to regular meals. Ideally, the ONS should be taken as a snack outside of meal times so as to not spoil the appetite. If this ONS is insufficient to improve the nutritional status of the patient, artificial nutrition (either enteral or parenteral) will be discussed.