A phase III study evaluating oral glutamine and transforming growth factor-beta 2 on chemotherapy-induced toxicity in patients with digestive neoplasm.
Dig Liver Dis
; 48(3): 327-32, 2016 Mar.
Article
de En
| MEDLINE
| ID: mdl-26776879
ABSTRACT
BACKGROUND:
Patients with gastrointestinal (GI) cancer are exposed to cachexia, which is highly correlated with chemotherapy-induced side effects. Research suggests that specific immunonutrients could prevent such toxicities.AIMS:
The primary objective of this phase III study was to evaluate the efficacy of glutamine and transforming growth factor-ß2 (TGF-ß2) in the prevention of grade 3-4 non-hematological toxicities induced by chemotherapy in patients with GI cancer. PATIENTS ANDMETHODS:
We designed a double-blind, randomized, controlled and multicenter trial stratified according to center, type of chemotherapy, presence of cachexia, and age. Patients were randomized to receive either Clinutren Protect(®) (CP) or a control isocaloric diet (without TGF-ß2 or glutamine).RESULTS:
Between November 2007 and October 2011, 210 patients were enrolled in the study, of which 201 were included in the intention-to-treat analysis. Grade 3-4 non-hematological toxicities were not significantly different between the CP and control groups when evaluated by univariate and multivariate analyses. Likewise, no difference was observed regarding grade 3-4 hematological toxicities or reasons for treatment interruption.CONCLUSION:
This randomized study does not support the hypothesis that oral glutamine and TGF-ß2 supplementation is effective to reduce grade 3 or 4 non-hematological toxicities induced by chemotherapy in patients with GI neoplasm.Mots clés
Texte intégral:
1
Collection:
01-internacional
Base de données:
MEDLINE
Sujet principal:
Protocoles de polychimiothérapie antinéoplasique
/
Facteur de croissance transformant bêta
/
Compléments alimentaires
/
Maladies gastro-intestinales
/
Tumeurs gastro-intestinales
/
Glutamine
Type d'étude:
Clinical_trials
Limites:
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Langue:
En
Journal:
Dig Liver Dis
Sujet du journal:
GASTROENTEROLOGIA
Année:
2016
Type de document:
Article
Pays d'affiliation:
France