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

Faïza Khemissa; Laurent Mineur; Caroline Amsellem; Eric Assenat; Mohamed Ramdani; Patrick Bachmann; Chloé Janiszewski; Isabelle Cristiani; Fideline Collin; Julie Courraud; Hélène de Forges; Pierre Dechelotte; Pierre Senesse

doi:10.1016/j.dld.2015.11.025

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

Faïza Khemissa, Laurent Mineur, Caroline Amsellem, Eric Assenat, Mohamed Ramdani, Patrick Bachmann, Chloé Janiszewski, Isabelle Cristiani, Fideline Collin, Julie Courraud, Hélène de Forges, Pierre Dechelotte, Pierre Senesse

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

8 Citationer (Scopus)

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-β2 (TGF-β2) 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-β2 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-β2 supplementation is effective to reduce grade 3 or 4 non-hematological toxicities induced by chemotherapy in patients with GI neoplasm.

Originalsprog	Engelsk
Tidsskrift	Digestive and Liver Disease
Vol/bind	48
Udgave nummer	3
Sider (fra-til)	327-332
Antal sider	6
ISSN	1590-8658
DOI	https://doi.org/10.1016/j.dld.2015.11.025
Status	Udgivet - 2016
Udgivet eksternt	Ja

Adgang til dokumentet

10.1016/j.dld.2015.11.025

Citationsformater

Khemissa, F., Mineur, L., Amsellem, C., Assenat, E., Ramdani, M., Bachmann, P., Janiszewski, C., Cristiani, I., Collin, F., Courraud, J., de Forges, H., Dechelotte, P., & Senesse, P. (2016). A phase III study evaluating oral glutamine and transforming growth factor-beta 2 on chemotherapy-induced toxicity in patients with digestive neoplasm. Digestive and Liver Disease, 48(3), 327-332. https://doi.org/10.1016/j.dld.2015.11.025

Khemissa, F, Mineur, L, Amsellem, C, Assenat, E, Ramdani, M, Bachmann, P, Janiszewski, C, Cristiani, I, Collin, F, Courraud, J, de Forges, H, Dechelotte, P & Senesse, P 2016, 'A phase III study evaluating oral glutamine and transforming growth factor-beta 2 on chemotherapy-induced toxicity in patients with digestive neoplasm', Digestive and Liver Disease, bind 48, nr. 3, s. 327-332. https://doi.org/10.1016/j.dld.2015.11.025

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

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-β2 (TGF-β2) 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({\textregistered}) (CP) or a control isocaloric diet (without TGF-β2 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-β2 supplementation is effective to reduce grade 3 or 4 non-hematological toxicities induced by chemotherapy in patients with GI neoplasm.",

author = "Fa{\"i}za Khemissa and Laurent Mineur and Caroline Amsellem and Eric Assenat and Mohamed Ramdani and Patrick Bachmann and Chlo{\'e} Janiszewski and Isabelle Cristiani and Fideline Collin and Julie Courraud and {de Forges}, H{\'e}l{\`e}ne and Pierre Dechelotte and Pierre Senesse",

year = "2016",

doi = "10.1016/j.dld.2015.11.025",

language = "English",

volume = "48",

pages = "327--332",

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T1 - A phase III study evaluating oral glutamine and transforming growth factor-beta 2 on chemotherapy-induced toxicity in patients with digestive neoplasm

AU - Khemissa, Faïza

AU - Mineur, Laurent

AU - Amsellem, Caroline

AU - Assenat, Eric

AU - Ramdani, Mohamed

AU - Bachmann, Patrick

AU - Janiszewski, Chloé

AU - Cristiani, Isabelle

AU - Collin, Fideline

AU - Courraud, Julie

AU - de Forges, Hélène

AU - Dechelotte, Pierre

AU - Senesse, Pierre

PY - 2016

Y1 - 2016

N2 - 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-β2 (TGF-β2) 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-β2 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-β2 supplementation is effective to reduce grade 3 or 4 non-hematological toxicities induced by chemotherapy in patients with GI neoplasm.

AB - 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-β2 (TGF-β2) 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-β2 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-β2 supplementation is effective to reduce grade 3 or 4 non-hematological toxicities induced by chemotherapy in patients with GI neoplasm.

U2 - 10.1016/j.dld.2015.11.025

DO - 10.1016/j.dld.2015.11.025

M3 - Journal article

C2 - 26776879

SN - 1590-8658

VL - 48

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EP - 332

JO - Digestive and Liver Disease

JF - Digestive and Liver Disease

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ER -