PROPERTY: study protocol for a randomized, double-blind, multicenter placebo-controlled trial assessing neurotoxicity in patients with metastatic gastrointestinal cancer taking PHYCOCARE® during oxaliplatin-based chemotherapy
Abstract Background Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common adverse effects of antineoplastic agents, ranging in prevalence from 19% to over 85%. Clinically, CIPN is a predominantly sensory neuropathy that may be accompanied by motor and autonomic changes of varyi...
Ausführliche Beschreibung
Autor*in: |
Christele Le Gouill-Jaijarat [verfasserIn] Yann Péréon [verfasserIn] Maxime Leroy [verfasserIn] Olivier Lépine [verfasserIn] Aymeric Loloum [verfasserIn] Claire Peluchon [verfasserIn] Christelle Volteau [verfasserIn] Anne-Sophie Martineau [verfasserIn] Simon Korner [verfasserIn] Caroline Perrault [verfasserIn] Asmahane Benmaziane [verfasserIn] Paul Girot [verfasserIn] Caroline Petorin [verfasserIn] Clément Perret [verfasserIn] Catherine Ligeza-Poisson [verfasserIn] Didier Mayeur [verfasserIn] Laurent Flet [verfasserIn] Anne Chiffoleau [verfasserIn] Alexandra Poinas [verfasserIn] Jaafar Bennouna [verfasserIn] |
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E-Artikel |
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Sprache: |
Englisch |
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2023 |
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Übergeordnetes Werk: |
In: Trials - BMC, 2006, 24(2023), 1, Seite 13 |
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Übergeordnetes Werk: |
volume:24 ; year:2023 ; number:1 ; pages:13 |
Links: |
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DOI / URN: |
10.1186/s13063-023-07071-z |
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Katalog-ID: |
DOAJ081642245 |
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520 | |a Abstract Background Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common adverse effects of antineoplastic agents, ranging in prevalence from 19% to over 85%. Clinically, CIPN is a predominantly sensory neuropathy that may be accompanied by motor and autonomic changes of varying intensity and duration. The high prevalence of CIPN among cancer patients makes it a major problem for both patients and survivors, as well as for their health care providers, especially because there is currently no single effective method of preventing CIPN; moreover, the options for treating this syndrome are very limited. Phycocyanin, a biliprotein pigment and an important constituent of the blue-green algae Spirulina platensis, has been reported to possess significant antioxidant and radical-scavenging properties, offering protection against oxidative stress, which is one of the hypothetic mechanisms, between others, of CIPN occurrence. Methods Our hypothesis is that phycocyanin may give protection against oxaliplatin-induced neuropathy in the treatment of gastrointestinal cancers. Our trial will be a randomized double-blind placebo-controlled study with 110 randomized patients suffering from metastatic gastrointestinal adenocarcinoma including esogastric, colorectal, and pancreatic cancers. Patients are being followed up in the gastroenterology or oncology departments of seven French hospitals. Discussion Due to the neuropathy, patients need to avoid injury by paying careful attention to home safety; patients’ physicians often prescribe over-the-counter pain medications. If validated, our hypothesis should help to limit neurotoxicity without the need to discontinue chemotherapy. Trial registration ClinicalTrials.gov NCT05025826. First published on August 27, 2021. | ||
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650 | 4 | |a Neurotoxicity | |
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650 | 4 | |a Oxaliplatin | |
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700 | 0 | |a Olivier Lépine |e verfasserin |4 aut | |
700 | 0 | |a Aymeric Loloum |e verfasserin |4 aut | |
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700 | 0 | |a Paul Girot |e verfasserin |4 aut | |
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10.1186/s13063-023-07071-z doi (DE-627)DOAJ081642245 (DE-599)DOAJf22ee8547f224ffa974ca0cab49d9ee4 DE-627 ger DE-627 rakwb eng R5-920 Christele Le Gouill-Jaijarat verfasserin aut PROPERTY: study protocol for a randomized, double-blind, multicenter placebo-controlled trial assessing neurotoxicity in patients with metastatic gastrointestinal cancer taking PHYCOCARE® during oxaliplatin-based chemotherapy 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common adverse effects of antineoplastic agents, ranging in prevalence from 19% to over 85%. Clinically, CIPN is a predominantly sensory neuropathy that may be accompanied by motor and autonomic changes of varying intensity and duration. The high prevalence of CIPN among cancer patients makes it a major problem for both patients and survivors, as well as for their health care providers, especially because there is currently no single effective method of preventing CIPN; moreover, the options for treating this syndrome are very limited. Phycocyanin, a biliprotein pigment and an important constituent of the blue-green algae Spirulina platensis, has been reported to possess significant antioxidant and radical-scavenging properties, offering protection against oxidative stress, which is one of the hypothetic mechanisms, between others, of CIPN occurrence. Methods Our hypothesis is that phycocyanin may give protection against oxaliplatin-induced neuropathy in the treatment of gastrointestinal cancers. Our trial will be a randomized double-blind placebo-controlled study with 110 randomized patients suffering from metastatic gastrointestinal adenocarcinoma including esogastric, colorectal, and pancreatic cancers. Patients are being followed up in the gastroenterology or oncology departments of seven French hospitals. Discussion Due to the neuropathy, patients need to avoid injury by paying careful attention to home safety; patients’ physicians often prescribe over-the-counter pain medications. If validated, our hypothesis should help to limit neurotoxicity without the need to discontinue chemotherapy. Trial registration ClinicalTrials.gov NCT05025826. First published on August 27, 2021. Chemotherapy-induced peripheral neuropathy Sensory neuropathy Neurotoxicity Spirulina extract Phycocyanin Oxaliplatin Medicine (General) Yann Péréon verfasserin aut Maxime Leroy verfasserin aut Olivier Lépine verfasserin aut Aymeric Loloum verfasserin aut Claire Peluchon verfasserin aut Christelle Volteau verfasserin aut Anne-Sophie Martineau verfasserin aut Simon Korner verfasserin aut Caroline Perrault verfasserin aut Asmahane Benmaziane verfasserin aut Paul Girot verfasserin aut Caroline Petorin verfasserin aut Clément Perret verfasserin aut Catherine Ligeza-Poisson verfasserin aut Didier Mayeur verfasserin aut Laurent Flet verfasserin aut Anne Chiffoleau verfasserin aut Alexandra Poinas verfasserin aut Jaafar Bennouna verfasserin aut In Trials BMC, 2006 24(2023), 1, Seite 13 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:24 year:2023 number:1 pages:13 https://doi.org/10.1186/s13063-023-07071-z kostenfrei https://doaj.org/article/f22ee8547f224ffa974ca0cab49d9ee4 kostenfrei https://doi.org/10.1186/s13063-023-07071-z kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 24 2023 1 13 |
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10.1186/s13063-023-07071-z doi (DE-627)DOAJ081642245 (DE-599)DOAJf22ee8547f224ffa974ca0cab49d9ee4 DE-627 ger DE-627 rakwb eng R5-920 Christele Le Gouill-Jaijarat verfasserin aut PROPERTY: study protocol for a randomized, double-blind, multicenter placebo-controlled trial assessing neurotoxicity in patients with metastatic gastrointestinal cancer taking PHYCOCARE® during oxaliplatin-based chemotherapy 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common adverse effects of antineoplastic agents, ranging in prevalence from 19% to over 85%. Clinically, CIPN is a predominantly sensory neuropathy that may be accompanied by motor and autonomic changes of varying intensity and duration. The high prevalence of CIPN among cancer patients makes it a major problem for both patients and survivors, as well as for their health care providers, especially because there is currently no single effective method of preventing CIPN; moreover, the options for treating this syndrome are very limited. Phycocyanin, a biliprotein pigment and an important constituent of the blue-green algae Spirulina platensis, has been reported to possess significant antioxidant and radical-scavenging properties, offering protection against oxidative stress, which is one of the hypothetic mechanisms, between others, of CIPN occurrence. Methods Our hypothesis is that phycocyanin may give protection against oxaliplatin-induced neuropathy in the treatment of gastrointestinal cancers. Our trial will be a randomized double-blind placebo-controlled study with 110 randomized patients suffering from metastatic gastrointestinal adenocarcinoma including esogastric, colorectal, and pancreatic cancers. Patients are being followed up in the gastroenterology or oncology departments of seven French hospitals. Discussion Due to the neuropathy, patients need to avoid injury by paying careful attention to home safety; patients’ physicians often prescribe over-the-counter pain medications. If validated, our hypothesis should help to limit neurotoxicity without the need to discontinue chemotherapy. Trial registration ClinicalTrials.gov NCT05025826. First published on August 27, 2021. Chemotherapy-induced peripheral neuropathy Sensory neuropathy Neurotoxicity Spirulina extract Phycocyanin Oxaliplatin Medicine (General) Yann Péréon verfasserin aut Maxime Leroy verfasserin aut Olivier Lépine verfasserin aut Aymeric Loloum verfasserin aut Claire Peluchon verfasserin aut Christelle Volteau verfasserin aut Anne-Sophie Martineau verfasserin aut Simon Korner verfasserin aut Caroline Perrault verfasserin aut Asmahane Benmaziane verfasserin aut Paul Girot verfasserin aut Caroline Petorin verfasserin aut Clément Perret verfasserin aut Catherine Ligeza-Poisson verfasserin aut Didier Mayeur verfasserin aut Laurent Flet verfasserin aut Anne Chiffoleau verfasserin aut Alexandra Poinas verfasserin aut Jaafar Bennouna verfasserin aut In Trials BMC, 2006 24(2023), 1, Seite 13 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:24 year:2023 number:1 pages:13 https://doi.org/10.1186/s13063-023-07071-z kostenfrei https://doaj.org/article/f22ee8547f224ffa974ca0cab49d9ee4 kostenfrei https://doi.org/10.1186/s13063-023-07071-z kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 24 2023 1 13 |
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10.1186/s13063-023-07071-z doi (DE-627)DOAJ081642245 (DE-599)DOAJf22ee8547f224ffa974ca0cab49d9ee4 DE-627 ger DE-627 rakwb eng R5-920 Christele Le Gouill-Jaijarat verfasserin aut PROPERTY: study protocol for a randomized, double-blind, multicenter placebo-controlled trial assessing neurotoxicity in patients with metastatic gastrointestinal cancer taking PHYCOCARE® during oxaliplatin-based chemotherapy 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common adverse effects of antineoplastic agents, ranging in prevalence from 19% to over 85%. Clinically, CIPN is a predominantly sensory neuropathy that may be accompanied by motor and autonomic changes of varying intensity and duration. The high prevalence of CIPN among cancer patients makes it a major problem for both patients and survivors, as well as for their health care providers, especially because there is currently no single effective method of preventing CIPN; moreover, the options for treating this syndrome are very limited. Phycocyanin, a biliprotein pigment and an important constituent of the blue-green algae Spirulina platensis, has been reported to possess significant antioxidant and radical-scavenging properties, offering protection against oxidative stress, which is one of the hypothetic mechanisms, between others, of CIPN occurrence. Methods Our hypothesis is that phycocyanin may give protection against oxaliplatin-induced neuropathy in the treatment of gastrointestinal cancers. Our trial will be a randomized double-blind placebo-controlled study with 110 randomized patients suffering from metastatic gastrointestinal adenocarcinoma including esogastric, colorectal, and pancreatic cancers. Patients are being followed up in the gastroenterology or oncology departments of seven French hospitals. Discussion Due to the neuropathy, patients need to avoid injury by paying careful attention to home safety; patients’ physicians often prescribe over-the-counter pain medications. If validated, our hypothesis should help to limit neurotoxicity without the need to discontinue chemotherapy. Trial registration ClinicalTrials.gov NCT05025826. First published on August 27, 2021. Chemotherapy-induced peripheral neuropathy Sensory neuropathy Neurotoxicity Spirulina extract Phycocyanin Oxaliplatin Medicine (General) Yann Péréon verfasserin aut Maxime Leroy verfasserin aut Olivier Lépine verfasserin aut Aymeric Loloum verfasserin aut Claire Peluchon verfasserin aut Christelle Volteau verfasserin aut Anne-Sophie Martineau verfasserin aut Simon Korner verfasserin aut Caroline Perrault verfasserin aut Asmahane Benmaziane verfasserin aut Paul Girot verfasserin aut Caroline Petorin verfasserin aut Clément Perret verfasserin aut Catherine Ligeza-Poisson verfasserin aut Didier Mayeur verfasserin aut Laurent Flet verfasserin aut Anne Chiffoleau verfasserin aut Alexandra Poinas verfasserin aut Jaafar Bennouna verfasserin aut In Trials BMC, 2006 24(2023), 1, Seite 13 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:24 year:2023 number:1 pages:13 https://doi.org/10.1186/s13063-023-07071-z kostenfrei https://doaj.org/article/f22ee8547f224ffa974ca0cab49d9ee4 kostenfrei https://doi.org/10.1186/s13063-023-07071-z kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 24 2023 1 13 |
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10.1186/s13063-023-07071-z doi (DE-627)DOAJ081642245 (DE-599)DOAJf22ee8547f224ffa974ca0cab49d9ee4 DE-627 ger DE-627 rakwb eng R5-920 Christele Le Gouill-Jaijarat verfasserin aut PROPERTY: study protocol for a randomized, double-blind, multicenter placebo-controlled trial assessing neurotoxicity in patients with metastatic gastrointestinal cancer taking PHYCOCARE® during oxaliplatin-based chemotherapy 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common adverse effects of antineoplastic agents, ranging in prevalence from 19% to over 85%. Clinically, CIPN is a predominantly sensory neuropathy that may be accompanied by motor and autonomic changes of varying intensity and duration. The high prevalence of CIPN among cancer patients makes it a major problem for both patients and survivors, as well as for their health care providers, especially because there is currently no single effective method of preventing CIPN; moreover, the options for treating this syndrome are very limited. Phycocyanin, a biliprotein pigment and an important constituent of the blue-green algae Spirulina platensis, has been reported to possess significant antioxidant and radical-scavenging properties, offering protection against oxidative stress, which is one of the hypothetic mechanisms, between others, of CIPN occurrence. Methods Our hypothesis is that phycocyanin may give protection against oxaliplatin-induced neuropathy in the treatment of gastrointestinal cancers. Our trial will be a randomized double-blind placebo-controlled study with 110 randomized patients suffering from metastatic gastrointestinal adenocarcinoma including esogastric, colorectal, and pancreatic cancers. Patients are being followed up in the gastroenterology or oncology departments of seven French hospitals. Discussion Due to the neuropathy, patients need to avoid injury by paying careful attention to home safety; patients’ physicians often prescribe over-the-counter pain medications. If validated, our hypothesis should help to limit neurotoxicity without the need to discontinue chemotherapy. Trial registration ClinicalTrials.gov NCT05025826. First published on August 27, 2021. Chemotherapy-induced peripheral neuropathy Sensory neuropathy Neurotoxicity Spirulina extract Phycocyanin Oxaliplatin Medicine (General) Yann Péréon verfasserin aut Maxime Leroy verfasserin aut Olivier Lépine verfasserin aut Aymeric Loloum verfasserin aut Claire Peluchon verfasserin aut Christelle Volteau verfasserin aut Anne-Sophie Martineau verfasserin aut Simon Korner verfasserin aut Caroline Perrault verfasserin aut Asmahane Benmaziane verfasserin aut Paul Girot verfasserin aut Caroline Petorin verfasserin aut Clément Perret verfasserin aut Catherine Ligeza-Poisson verfasserin aut Didier Mayeur verfasserin aut Laurent Flet verfasserin aut Anne Chiffoleau verfasserin aut Alexandra Poinas verfasserin aut Jaafar Bennouna verfasserin aut In Trials BMC, 2006 24(2023), 1, Seite 13 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:24 year:2023 number:1 pages:13 https://doi.org/10.1186/s13063-023-07071-z kostenfrei https://doaj.org/article/f22ee8547f224ffa974ca0cab49d9ee4 kostenfrei https://doi.org/10.1186/s13063-023-07071-z kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 24 2023 1 13 |
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R5-920 PROPERTY: study protocol for a randomized, double-blind, multicenter placebo-controlled trial assessing neurotoxicity in patients with metastatic gastrointestinal cancer taking PHYCOCARE® during oxaliplatin-based chemotherapy Chemotherapy-induced peripheral neuropathy Sensory neuropathy Neurotoxicity Spirulina extract Phycocyanin Oxaliplatin |
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PROPERTY: study protocol for a randomized, double-blind, multicenter placebo-controlled trial assessing neurotoxicity in patients with metastatic gastrointestinal cancer taking PHYCOCARE® during oxaliplatin-based chemotherapy |
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Christele Le Gouill-Jaijarat Yann Péréon Maxime Leroy Olivier Lépine Aymeric Loloum Claire Peluchon Christelle Volteau Anne-Sophie Martineau Simon Korner Caroline Perrault Asmahane Benmaziane Paul Girot Caroline Petorin Clément Perret Catherine Ligeza-Poisson Didier Mayeur Laurent Flet Anne Chiffoleau Alexandra Poinas Jaafar Bennouna |
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property: study protocol for a randomized, double-blind, multicenter placebo-controlled trial assessing neurotoxicity in patients with metastatic gastrointestinal cancer taking phycocare® during oxaliplatin-based chemotherapy |
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PROPERTY: study protocol for a randomized, double-blind, multicenter placebo-controlled trial assessing neurotoxicity in patients with metastatic gastrointestinal cancer taking PHYCOCARE® during oxaliplatin-based chemotherapy |
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Abstract Background Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common adverse effects of antineoplastic agents, ranging in prevalence from 19% to over 85%. Clinically, CIPN is a predominantly sensory neuropathy that may be accompanied by motor and autonomic changes of varying intensity and duration. The high prevalence of CIPN among cancer patients makes it a major problem for both patients and survivors, as well as for their health care providers, especially because there is currently no single effective method of preventing CIPN; moreover, the options for treating this syndrome are very limited. Phycocyanin, a biliprotein pigment and an important constituent of the blue-green algae Spirulina platensis, has been reported to possess significant antioxidant and radical-scavenging properties, offering protection against oxidative stress, which is one of the hypothetic mechanisms, between others, of CIPN occurrence. Methods Our hypothesis is that phycocyanin may give protection against oxaliplatin-induced neuropathy in the treatment of gastrointestinal cancers. Our trial will be a randomized double-blind placebo-controlled study with 110 randomized patients suffering from metastatic gastrointestinal adenocarcinoma including esogastric, colorectal, and pancreatic cancers. Patients are being followed up in the gastroenterology or oncology departments of seven French hospitals. Discussion Due to the neuropathy, patients need to avoid injury by paying careful attention to home safety; patients’ physicians often prescribe over-the-counter pain medications. If validated, our hypothesis should help to limit neurotoxicity without the need to discontinue chemotherapy. Trial registration ClinicalTrials.gov NCT05025826. First published on August 27, 2021. |
abstractGer |
Abstract Background Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common adverse effects of antineoplastic agents, ranging in prevalence from 19% to over 85%. Clinically, CIPN is a predominantly sensory neuropathy that may be accompanied by motor and autonomic changes of varying intensity and duration. The high prevalence of CIPN among cancer patients makes it a major problem for both patients and survivors, as well as for their health care providers, especially because there is currently no single effective method of preventing CIPN; moreover, the options for treating this syndrome are very limited. Phycocyanin, a biliprotein pigment and an important constituent of the blue-green algae Spirulina platensis, has been reported to possess significant antioxidant and radical-scavenging properties, offering protection against oxidative stress, which is one of the hypothetic mechanisms, between others, of CIPN occurrence. Methods Our hypothesis is that phycocyanin may give protection against oxaliplatin-induced neuropathy in the treatment of gastrointestinal cancers. Our trial will be a randomized double-blind placebo-controlled study with 110 randomized patients suffering from metastatic gastrointestinal adenocarcinoma including esogastric, colorectal, and pancreatic cancers. Patients are being followed up in the gastroenterology or oncology departments of seven French hospitals. Discussion Due to the neuropathy, patients need to avoid injury by paying careful attention to home safety; patients’ physicians often prescribe over-the-counter pain medications. If validated, our hypothesis should help to limit neurotoxicity without the need to discontinue chemotherapy. Trial registration ClinicalTrials.gov NCT05025826. First published on August 27, 2021. |
abstract_unstemmed |
Abstract Background Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common adverse effects of antineoplastic agents, ranging in prevalence from 19% to over 85%. Clinically, CIPN is a predominantly sensory neuropathy that may be accompanied by motor and autonomic changes of varying intensity and duration. The high prevalence of CIPN among cancer patients makes it a major problem for both patients and survivors, as well as for their health care providers, especially because there is currently no single effective method of preventing CIPN; moreover, the options for treating this syndrome are very limited. Phycocyanin, a biliprotein pigment and an important constituent of the blue-green algae Spirulina platensis, has been reported to possess significant antioxidant and radical-scavenging properties, offering protection against oxidative stress, which is one of the hypothetic mechanisms, between others, of CIPN occurrence. Methods Our hypothesis is that phycocyanin may give protection against oxaliplatin-induced neuropathy in the treatment of gastrointestinal cancers. Our trial will be a randomized double-blind placebo-controlled study with 110 randomized patients suffering from metastatic gastrointestinal adenocarcinoma including esogastric, colorectal, and pancreatic cancers. Patients are being followed up in the gastroenterology or oncology departments of seven French hospitals. Discussion Due to the neuropathy, patients need to avoid injury by paying careful attention to home safety; patients’ physicians often prescribe over-the-counter pain medications. If validated, our hypothesis should help to limit neurotoxicity without the need to discontinue chemotherapy. Trial registration ClinicalTrials.gov NCT05025826. First published on August 27, 2021. |
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PROPERTY: study protocol for a randomized, double-blind, multicenter placebo-controlled trial assessing neurotoxicity in patients with metastatic gastrointestinal cancer taking PHYCOCARE® during oxaliplatin-based chemotherapy |
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