| Added by | adjiane.lab |
|---|---|
| Group name | EquipeAD |
| Item Type | Journal Article |
| Title | A phase III study evaluating oral glutamine and transforming growth factor-beta 2 on chemotherapy-induced toxicity in patients with digestive neoplasm |
| Creator | Khemissa et al. |
| Author | Laurent Mineur |
| Author | Caroline Amsellem |
| Author | Eric Assenat |
| Author | Mohamed Ramdani |
| Author | Patrick Bachmann |
| Author | Chloé Janiszewski |
| Author | Isabelle Cristiani |
| Author | Fideline Collin |
| Author | Julie Courraud |
| Author | Hélène de Forges |
| Author | Pierre Dechelotte |
| Author | Pierre Senesse |
| 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-?2 (TGF-?2) in the prevention of grade 3-4 non-hematological toxicities induced by chemotherapy in patients with GI cancer. PATIENTS AND METHODS: 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-?2 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-?2 supplementation is effective to reduce grade 3 or 4 non-hematological toxicities induced by chemotherapy in patients with GI neoplasm. |
| Publication | Digestive and Liver Disease: Official Journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver |
| Volume | 48 |
| Issue | 3 |
| Pages | 327-332 |
| Date | 2016-03 |
| Journal Abbr | Dig Liver Dis |
| Language | eng |
| DOI | 10.1016/j.dld.2015.11.025 |
| ISSN | 1878-3562 |
| Library Catalog | PubMed |
| Extra | PMID: 26776879 |
| Tags | Aged, Antineoplastic Combined Chemotherapy Protocols, Cachexia, Chemotherapy, clinic, Dietary Supplements, Double-Blind Method, Female, Fluorouracil, Gastrointestinal Diseases, Gastrointestinal Neoplasms, Glutamine, Humans, last, Male, Middle Aged, Platinum Compounds, Side effects, Transforming Growth Factor beta |
| Date Added | 2024/09/30 - 01:33:15 |
| Date Modified | 2024/09/30 - 18:24:44 |
| Notes and Attachments | PubMed entry (Attachment) |
Institut de Recherche en Cancérologie de
