Efficacy of an Oral Formula in Prevention of Anti-cancer Therapy Side Effects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2012-01-31

Brief Summary

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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 intervention with the product could abrogate the undesired effects in a preventive manner.

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Detailed Description

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Conditions

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Digestive Cancers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Glutamine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No