A randomized controlled trial evaluating the efficacy and safety of vitamin E supplementation for protection against cisplatin-induced peripheral neuropathy: final results
A randomized, open label with blind assessment, controlled trial was performed to assess efficacy and adverse-event profile of vitamin E, given as supplementation for prophylaxis against cisplatin-induced peripheral neuropathy (CIPN). A total of 30 patients scheduled to receive six courses of cumula...
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| Veröffentlicht in: | Supportive care in cancer 2006-11, Vol.14 (11), p.1134-1140 |
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| creator | Argyriou, Andreas A Chroni, Elisabeth Koutras, Angelos Iconomou, Gregoris Papapetropoulos, Spiridon Polychronopoulos, Panagiotis Kalofonos, Haralabos P |
| description | A randomized, open label with blind assessment, controlled trial was performed to assess efficacy and adverse-event profile of vitamin E, given as supplementation for prophylaxis against cisplatin-induced peripheral neuropathy (CIPN).
A total of 30 patients scheduled to receive six courses of cumulative cisplatin-based regimens were randomly allocated to treatment and control groups and were then studied by means of neurological examination and electrophysiological study. Patients assigned to group I (n=14) orally received vitamin E at a daily dose of 600 mg/day during chemotherapy and 3 months after its cessation were compared to patients of group II (n=16), who received no vitamin E supplementation and served as controls. The severity of neurotoxicity was summarized by means of a modified Peripheral Neuropathy (PNP) score.
The incidence of neurotoxicity differed significantly between groups, occurring in 3/14 (21.4%) of patients assigned to the vitamin E supplementation group and in 11/16 (68.5%) of controls (p=0.026). The relative risk (RR) of developing neurotoxicity was significantly higher in case of controls, RR=2.51, 95% C.I.=1.16-5.47. Mean PNP scores were 4.99+/-1.33 for patients of group I and 10.47+/-10.62 for controls, (p=0.023). None of the adverse events or deaths occurred, were judged as likely to be related to the vitamin E supplementation.
Vitamin E effectively and safely protects patients with cancer from occurrence of cisplatin neurotoxicity. |
| doi_str_mv | 10.1007/s00520-006-0072-3 |
| format | Article |
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A total of 30 patients scheduled to receive six courses of cumulative cisplatin-based regimens were randomly allocated to treatment and control groups and were then studied by means of neurological examination and electrophysiological study. Patients assigned to group I (n=14) orally received vitamin E at a daily dose of 600 mg/day during chemotherapy and 3 months after its cessation were compared to patients of group II (n=16), who received no vitamin E supplementation and served as controls. The severity of neurotoxicity was summarized by means of a modified Peripheral Neuropathy (PNP) score.
The incidence of neurotoxicity differed significantly between groups, occurring in 3/14 (21.4%) of patients assigned to the vitamin E supplementation group and in 11/16 (68.5%) of controls (p=0.026). The relative risk (RR) of developing neurotoxicity was significantly higher in case of controls, RR=2.51, 95% C.I.=1.16-5.47. Mean PNP scores were 4.99+/-1.33 for patients of group I and 10.47+/-10.62 for controls, (p=0.023). None of the adverse events or deaths occurred, were judged as likely to be related to the vitamin E supplementation.
Vitamin E effectively and safely protects patients with cancer from occurrence of cisplatin neurotoxicity.</description><identifier>ISSN: 0941-4355</identifier><identifier>EISSN: 1433-7339</identifier><identifier>DOI: 10.1007/s00520-006-0072-3</identifier><identifier>PMID: 16622646</identifier><language>eng</language><publisher>Germany: Springer Nature B.V</publisher><subject>Action Potentials - drug effects ; Adult ; Aged ; Antineoplastic Agents - administration & dosage ; Antineoplastic Agents - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antioxidants - adverse effects ; Antioxidants - therapeutic use ; Carcinoma, Small Cell - drug therapy ; Cisplatin - administration & dosage ; Cisplatin - adverse effects ; Clinical trials ; Dietary Supplements ; Double-Blind Method ; Female ; Head and Neck Neoplasms - drug therapy ; Humans ; Incidence ; Lung Neoplasms - drug therapy ; Male ; Middle Aged ; Neurotoxicity ; Peripheral Nervous System Diseases - chemically induced ; Peripheral Nervous System Diseases - physiopathology ; Peripheral Nervous System Diseases - prevention & control ; Peroneal Nerve - drug effects ; Peroneal Nerve - physiopathology ; Psychomotor Performance - drug effects ; Research Design ; Severity of Illness Index ; Stomach Neoplasms - drug therapy ; Testicular Neoplasms - drug therapy ; Treatment Outcome ; Ulnar Nerve - drug effects ; Ulnar Nerve - physiopathology ; Uterine Cervical Neoplasms - drug therapy ; Vitamin E ; Vitamin E - adverse effects ; Vitamin E - therapeutic use</subject><ispartof>Supportive care in cancer, 2006-11, Vol.14 (11), p.1134-1140</ispartof><rights>Springer-Verlag 2006.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c326t-95a2e978dd2a8c4d8f61d7c36db47ce2873a196e0107e8e992fd1bd3218ec7593</citedby><cites>FETCH-LOGICAL-c326t-95a2e978dd2a8c4d8f61d7c36db47ce2873a196e0107e8e992fd1bd3218ec7593</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,777,781,27906,27907</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16622646$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Argyriou, Andreas A</creatorcontrib><creatorcontrib>Chroni, Elisabeth</creatorcontrib><creatorcontrib>Koutras, Angelos</creatorcontrib><creatorcontrib>Iconomou, Gregoris</creatorcontrib><creatorcontrib>Papapetropoulos, Spiridon</creatorcontrib><creatorcontrib>Polychronopoulos, Panagiotis</creatorcontrib><creatorcontrib>Kalofonos, Haralabos P</creatorcontrib><title>A randomized controlled trial evaluating the efficacy and safety of vitamin E supplementation for protection against cisplatin-induced peripheral neuropathy: final results</title><title>Supportive care in cancer</title><addtitle>Support Care Cancer</addtitle><description>A randomized, open label with blind assessment, controlled trial was performed to assess efficacy and adverse-event profile of vitamin E, given as supplementation for prophylaxis against cisplatin-induced peripheral neuropathy (CIPN).
A total of 30 patients scheduled to receive six courses of cumulative cisplatin-based regimens were randomly allocated to treatment and control groups and were then studied by means of neurological examination and electrophysiological study. Patients assigned to group I (n=14) orally received vitamin E at a daily dose of 600 mg/day during chemotherapy and 3 months after its cessation were compared to patients of group II (n=16), who received no vitamin E supplementation and served as controls. The severity of neurotoxicity was summarized by means of a modified Peripheral Neuropathy (PNP) score.
The incidence of neurotoxicity differed significantly between groups, occurring in 3/14 (21.4%) of patients assigned to the vitamin E supplementation group and in 11/16 (68.5%) of controls (p=0.026). The relative risk (RR) of developing neurotoxicity was significantly higher in case of controls, RR=2.51, 95% C.I.=1.16-5.47. Mean PNP scores were 4.99+/-1.33 for patients of group I and 10.47+/-10.62 for controls, (p=0.023). None of the adverse events or deaths occurred, were judged as likely to be related to the vitamin E supplementation.
Vitamin E effectively and safely protects patients with cancer from occurrence of cisplatin neurotoxicity.</description><subject>Action Potentials - drug effects</subject><subject>Adult</subject><subject>Aged</subject><subject>Antineoplastic Agents - administration & dosage</subject><subject>Antineoplastic Agents - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antioxidants - adverse effects</subject><subject>Antioxidants - therapeutic use</subject><subject>Carcinoma, Small Cell - drug therapy</subject><subject>Cisplatin - administration & dosage</subject><subject>Cisplatin - adverse effects</subject><subject>Clinical trials</subject><subject>Dietary Supplements</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Head and Neck Neoplasms - drug therapy</subject><subject>Humans</subject><subject>Incidence</subject><subject>Lung Neoplasms - drug therapy</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Neurotoxicity</subject><subject>Peripheral Nervous System Diseases - chemically induced</subject><subject>Peripheral Nervous System Diseases - physiopathology</subject><subject>Peripheral Nervous System Diseases - prevention & control</subject><subject>Peroneal Nerve - drug effects</subject><subject>Peroneal Nerve - physiopathology</subject><subject>Psychomotor Performance - drug effects</subject><subject>Research Design</subject><subject>Severity of Illness Index</subject><subject>Stomach Neoplasms - drug therapy</subject><subject>Testicular Neoplasms - drug therapy</subject><subject>Treatment Outcome</subject><subject>Ulnar Nerve - drug effects</subject><subject>Ulnar Nerve - physiopathology</subject><subject>Uterine Cervical Neoplasms - drug therapy</subject><subject>Vitamin E</subject><subject>Vitamin E - adverse effects</subject><subject>Vitamin E - therapeutic use</subject><issn>0941-4355</issn><issn>1433-7339</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2006</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNpFkduKFDEQhoMo7rj6AN5I8L41h-4cvFuW9QAL3uh1yCSVnSzdSZukF8ZX8iXNOANeFHWg_r8KPoTeUvKBEiI_VkImRgZCRA_JBv4M7ejI-SA518_RjuiRDiOfpiv0qtZHQqiUE3uJrqgQjIlR7NCfG1xs8nmJv8Fjl1MreZ572Uq0M4YnO2-2xfSA2wEwhBCddUfcJbjaAO2Ic8BPsdklJnyH67auMyyQWhflhEMueC25gfvX2gcbU23YxbrOJ9shJr-5fm6FEtcDlH4zwVbyatvh-AmHmPqkQN3mVl-jF8HOFd5c8jX6-fnux-3X4f77l2-3N_eD40y0QU-WgZbKe2aVG70KgnrpuPD7UTpgSnJLtQBCiQQFWrPg6d5zRhU4OWl-jd6fffvnvzaozTzmrfRHqlFqJFopNvYlel5yJddaIJi1xMWWo6HEnOiYMx3T6ZgTHcO75t3FeNsv4P8rLjj4X_bEj5U</recordid><startdate>200611</startdate><enddate>200611</enddate><creator>Argyriou, Andreas A</creator><creator>Chroni, Elisabeth</creator><creator>Koutras, Angelos</creator><creator>Iconomou, Gregoris</creator><creator>Papapetropoulos, Spiridon</creator><creator>Polychronopoulos, Panagiotis</creator><creator>Kalofonos, Haralabos P</creator><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>0-V</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88J</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>ALSLI</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HEHIP</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>M2R</scope><scope>M2S</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope></search><sort><creationdate>200611</creationdate><title>A randomized controlled trial evaluating the efficacy and safety of vitamin E supplementation for protection against cisplatin-induced peripheral neuropathy: final results</title><author>Argyriou, Andreas A ; Chroni, Elisabeth ; Koutras, Angelos ; Iconomou, Gregoris ; Papapetropoulos, Spiridon ; Polychronopoulos, Panagiotis ; Kalofonos, Haralabos P</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c326t-95a2e978dd2a8c4d8f61d7c36db47ce2873a196e0107e8e992fd1bd3218ec7593</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2006</creationdate><topic>Action Potentials - 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A total of 30 patients scheduled to receive six courses of cumulative cisplatin-based regimens were randomly allocated to treatment and control groups and were then studied by means of neurological examination and electrophysiological study. Patients assigned to group I (n=14) orally received vitamin E at a daily dose of 600 mg/day during chemotherapy and 3 months after its cessation were compared to patients of group II (n=16), who received no vitamin E supplementation and served as controls. The severity of neurotoxicity was summarized by means of a modified Peripheral Neuropathy (PNP) score.
The incidence of neurotoxicity differed significantly between groups, occurring in 3/14 (21.4%) of patients assigned to the vitamin E supplementation group and in 11/16 (68.5%) of controls (p=0.026). The relative risk (RR) of developing neurotoxicity was significantly higher in case of controls, RR=2.51, 95% C.I.=1.16-5.47. Mean PNP scores were 4.99+/-1.33 for patients of group I and 10.47+/-10.62 for controls, (p=0.023). None of the adverse events or deaths occurred, were judged as likely to be related to the vitamin E supplementation.
Vitamin E effectively and safely protects patients with cancer from occurrence of cisplatin neurotoxicity.</abstract><cop>Germany</cop><pub>Springer Nature B.V</pub><pmid>16622646</pmid><doi>10.1007/s00520-006-0072-3</doi><tpages>7</tpages></addata></record> |
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| ispartof | Supportive care in cancer, 2006-11, Vol.14 (11), p.1134-1140 |
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| subjects | Action Potentials - drug effects Adult Aged Antineoplastic Agents - administration & dosage Antineoplastic Agents - adverse effects Antineoplastic Combined Chemotherapy Protocols - adverse effects Antioxidants - adverse effects Antioxidants - therapeutic use Carcinoma, Small Cell - drug therapy Cisplatin - administration & dosage Cisplatin - adverse effects Clinical trials Dietary Supplements Double-Blind Method Female Head and Neck Neoplasms - drug therapy Humans Incidence Lung Neoplasms - drug therapy Male Middle Aged Neurotoxicity Peripheral Nervous System Diseases - chemically induced Peripheral Nervous System Diseases - physiopathology Peripheral Nervous System Diseases - prevention & control Peroneal Nerve - drug effects Peroneal Nerve - physiopathology Psychomotor Performance - drug effects Research Design Severity of Illness Index Stomach Neoplasms - drug therapy Testicular Neoplasms - drug therapy Treatment Outcome Ulnar Nerve - drug effects Ulnar Nerve - physiopathology Uterine Cervical Neoplasms - drug therapy Vitamin E Vitamin E - adverse effects Vitamin E - therapeutic use |
| title | A randomized controlled trial evaluating the efficacy and safety of vitamin E supplementation for protection against cisplatin-induced peripheral neuropathy: final results |
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