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Phase 3
18 Years
N/A
Not Enrolling
Both
Digestive Cancers

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Trial Information


Inclusion Criteria:



- 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 Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Principal Investigator

Pierre SENESSE, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CRLC Val d'Aurelle

Authority:

France: Ministry of Health

Study ID:

06.23.CLI

NCT ID:

NCT00455247

Start Date:

October 2007

Completion Date:

January 2012

Related Keywords:

  • Digestive Cancers
  • Gastrointestinal Neoplasms

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