A phase III study evaluating oral glutamine and transforming growth factor-beta 2 on chemotherapy-induced toxicity in patients with digestive neoplasm

被引:8
作者
Khemissa, Faiza [1 ]
Mineur, Laurent [2 ]
Amsellem, Caroline [3 ]
Assenat, Eric [4 ]
Ramdani, Mohamed [5 ]
Bachmann, Patrick [6 ]
Janiszewski, Chloe [7 ]
Cristiani, Isabelle [8 ]
Collin, Fideline [9 ]
Courraud, Julie [7 ]
de Forges, Helene [7 ]
Dechelotte, Pierre [3 ]
Senesse, Pierre [4 ,10 ,11 ]
机构
[1] Ctr Hosp Perpignan, Dept Gastroenterol, Perpignan, France
[2] Inst St Catherine, Digest Oncol & Radiotherapy Unit, Avignon 9, France
[3] Univ Rouen, Dept Nutr, INSERM, U1073,Inst Rech & Innovat Biomed, Rouen, France
[4] Inst Reg Canc Montpellier ICM, Dept Clin Nutr & Gastroenterol, 208 Ave Apothicaires, F-34298 Montpellier, France
[5] Ctr Hosp Beziers, Dept Gastroenterol, Beziers, France
[6] Ctr Leon Berard, Dept Clin Nutr, F-69373 Lyon, France
[7] Inst Reg Canc Montpellier ICM, Dept Clin Res, F-34298 Montpellier, France
[8] Nestle Res Ctr, CH-1000 Lausanne 26, Switzerland
[9] Ctr Hosp Perpignan, Dept Clin Res, Perpignan, France
[10] Inst Reg Canc Montpellier ICM, SIRIC Montpellier Canc, F-34298 Montpellier, France
[11] Univ Montpellier, Epsylon Lab, EA Dynam Human Abil & Hlth Behav 4556, F-34059 Montpellier, France
关键词
Chemotherapy; Gastrointestinal cancer; Immunonutrition; Side effects; RANDOMIZED CONTROLLED-TRIAL; COLORECTAL-CANCER PATIENTS; ANTICANCER TREATMENT; ENTERAL NUTRITION; ESPEN GUIDELINES; CROHNS-DISEASE; BREAST-CANCER; DOUBLE-BLIND; RADIOTHERAPY; PREVENTION;
D O I
10.1016/j.dld.2015.11.025
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
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-beta 2 (TGF-beta 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 (R) (CP) or a control isocaloric diet (without TGF-beta 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-beta 2 supplementation is effective to reduce grade 3 or 4 non-hematological toxicities induced by chemotherapy in patients with GI neoplasm. (C) 2015 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.
引用
收藏
页码:327 / 332
页数:6
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