Status:
COMPLETED
Efficacy of an Oral Formula in Prevention of Anti-cancer Therapy Side Effects
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Digestive Cancers
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Anti-cancer treatment is often inducing side-effects that can affect the compliance to the treatment protocol and quality of life of the patients. The researchers will study if the nutritional interve...
Eligibility Criteria
Inclusion
- Patient with GI neoplasm
- Patient that must start a (new) line of chemotherapy with at least 2 cycles
- Age \> 18 ans
- Exclusively orally fed
- Life expectancy more than 3 months
- Intravenous 5FU-based chemotherapy with 2 or 3-week cycles
- Hematological toxicities from previous chemotherapies terminated or \<= 2
Exclusion
- Positive HIV status
- Pregnant or lactating woman
- Currently participating or having participated in another clinical trial during the last month prior to the beginning of this study
- Patient having diarrhoea of grade \> 1 for more than 2 weeks before the inclusion
- State of sub occlusion, chronic inflammatory diseases of the digestive tract, radiation enteropathy
- Sepsis
- Concomitant radiotherapy, except analgesic radiotherapy
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
End Date :
January 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00455247
Start Date
October 1 2007
End Date
January 1 2012
Last Update
June 5 2013
Active Locations (7)
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1
Institut Sainte-Catherine
Avignon, France
2
CH Béziers
Béziers, France
3
CRLCC Léon Bérard
Lyon, France, 69008
4
CRLC Val d'Aurelle
Montpellier, France, 34090