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

Nestlé

Status and phase

Completed

Phase 3

Conditions

Digestive Cancers

Treatments

Drug: Glutamine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00455247

06.23.CLI

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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