Status:
COMPLETED
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
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Collaborating Sponsors:
UNICANCER
Centre Leon Berard
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Description of active nutritional support: Early and active nutritional support is mainly concerned with maintaining protein and energy intake levels despite chemotherapy. A part-time nutritionist wil...
Detailed Description
The "Nutricancer study" carried out on 2,000 French patients showed a malnutrition prevalence rate of 39% in cancer patients. Malnutrition is an independent risk factor for hospital-acquired infection...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT01143285
Start Date
April 1 2010
End Date
April 1 2016
Last Update
April 25 2016
Active Locations (8)
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1
Institut Sainte Catherine
Avignon, France, 84082
2
The Léon Bérard Cancer Centre
Lyon, France, 69373
3
Assistance Publique des hopitaux de Marseille
Marseille, France, 13385
4
The Val d'Aurelle Cancer Centre
Montpellier, France, 34298