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

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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Key information

Conditions

Digestive Cancers Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institut Sainte-Catherine, Avignon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

glutamine

Drug

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start: 2007
Primary completion: 2012
Study completion: 2012
First posted: Apr 3, 2007
Registry last updated: Jun 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed