{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,4]],"date-time":"2026-10-04T23:31:16Z","timestamp":1791156676858,"version":"4.1.0"},"reference-count":30,"publisher":"BMJ","issue":"4","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2015,3,12]]},"published-print":{"date-parts":[[2015,4]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Oxaliplatin remains the most widely used chemotherapeutic agent for treating advanced colorectal cancer but its efficacy is hampered by dose-limiting neurotoxicity manifested by a painful polyneuropathy. Oxaliplatin-induced peripheral neuropathy (OIPN) is characterised by acute and transient cold hyperaesthesia in the hours and days following oxaliplatin infusion (&gt;90% of patients), but also by retarded chronic neuropathy due to the repetition of chemotherapy cycles (30\u201350% of patients). OIPN impairs the health-related quality of life (HRQOL) of patients and no preventive or curative strategies have as yet proven effective. A polyamine-reduced diet (PRD) has recently demonstrated its efficacy to prevent OIPN in animals without adverse effects.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>The NEUROXAPOL trial is a prospective, randomised, controlled, single-blind, monocentric and interventional study. This trial is aimed at evaluating the efficacy and feasibility of a PRD compared to a normal polyamine containing diet to prevent OIPN in patients treated by oxaliplatin-based chemotherapy. Patients (n=40 per group) will be randomly assigned to receive either a PRD or a normal diet before and during the chemotherapy regimen. The main objectives are to improve the cold pain thresholds, neuropathic pain symptoms, comorbidities (anxiety and depression) and HRQOL of patients. The primary end point is the assessment of cold pain thresholds 2\u2005weeks after the third cycle of chemotherapy. The secondary end points are the evaluation of thermal pain thresholds, the grade of neuropathy, neuropathic pain, symptoms of anxiety and depression and HRQOL, until the 12th cycle of chemotherapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The study was approved by an independent medical ethics committee 1 (CPP Sud Est 1, Saint Etienne, France) and registered by the competent French authority (ANSM, Saint Denis, France). The results will be disseminated in a peer-reviewed journal and presented at international congresses.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>NCT01775449.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2014-007479","type":"journal-article","created":{"date-parts":[[2015,4,2]],"date-time":"2015-04-02T11:47:26Z","timestamp":1427975246000},"page":"e007479","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":23,"title":["Prevention of oxaliplatin-induced peripheral neuropathy by a polyamine-reduced diet\u2014NEUROXAPOL: protocol of a prospective, randomised, controlled, single-blind and monocentric trial"],"prefix":"10.1136","volume":"5","clinical-trial-number":[{"clinical-trial-number":"nct01775449","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"David","family":"Balayssac","sequence":"first","affiliation":[{"name":"Clermont Universit\u00e9, Clermont-Ferrand, France"},{"name":"INSERM, U1107 NEURO-DOL, Clermont-Ferrand, France"},{"name":"CHU Clermont-Ferrand, Clermont-Ferrand, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u00e9r\u00e9my","family":"Ferrier","sequence":"additional","affiliation":[{"name":"Clermont Universit\u00e9, Clermont-Ferrand, France"},{"name":"INSERM, U1107 NEURO-DOL, Clermont-Ferrand, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruno","family":"Pereira","sequence":"additional","affiliation":[{"name":"CHU Clermont-Ferrand, Clermont-Ferrand, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brigitte","family":"Gillet","sequence":"additional","affiliation":[{"name":"CHU Clermont-Ferrand, Clermont-Ferrand, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"P\u00e9torin","sequence":"additional","affiliation":[{"name":"CHU Clermont-Ferrand, Clermont-Ferrand, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie","family":"Vein","sequence":"additional","affiliation":[{"name":"Clermont Universit\u00e9, Clermont-Ferrand, France"},{"name":"INSERM, U1107 NEURO-DOL, Clermont-Ferrand, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fr\u00e9d\u00e9ric","family":"Libert","sequence":"additional","affiliation":[{"name":"Clermont Universit\u00e9, Clermont-Ferrand, France"},{"name":"INSERM, U1107 NEURO-DOL, Clermont-Ferrand, France"},{"name":"CHU Clermont-Ferrand, Clermont-Ferrand, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alain","family":"Eschalier","sequence":"additional","affiliation":[{"name":"Clermont Universit\u00e9, Clermont-Ferrand, France"},{"name":"INSERM, U1107 NEURO-DOL, Clermont-Ferrand, France"},{"name":"CHU Clermont-Ferrand, Clermont-Ferrand, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Denis","family":"Pezet","sequence":"additional","affiliation":[{"name":"Clermont Universit\u00e9, Clermont-Ferrand, France"},{"name":"CHU Clermont-Ferrand, Clermont-Ferrand, France"},{"name":"INSERM, U1071, Clermont-Ferrand, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2015,4,1]]},"reference":[{"key":"2025121512531857000_5.4.e007479.1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(13)70447-9"},{"key":"2025121512531857000_5.4.e007479.2","doi-asserted-by":"publisher","DOI":"10.1007\/s00520-014-2242-z"},{"key":"2025121512531857000_5.4.e007479.3","doi-asserted-by":"publisher","DOI":"10.1517\/14740338.2011.543417"},{"key":"2025121512531857000_5.4.e007479.4","doi-asserted-by":"publisher","DOI":"10.1089\/jpm.2010.0124"},{"key":"2025121512531857000_5.4.e007479.5","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2011.36.4539"},{"key":"2025121512531857000_5.4.e007479.6","doi-asserted-by":"publisher","DOI":"10.1016\/j.pain.2009.03.024"},{"key":"2025121512531857000_5.4.e007479.7","doi-asserted-by":"publisher","DOI":"10.1007\/s00520-013-1905-5"},{"key":"2025121512531857000_5.4.e007479.8","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2013.49.1514"},{"key":"2025121512531857000_5.4.e007479.9","doi-asserted-by":"crossref","unstructured":"Hershman DL , Lacchetti C , Dworkin RH , et al . Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol 32:1941\u201367. doi:10.1200\/JCO.2013.54.0914","DOI":"10.1200\/JCO.2013.54.0914"},{"key":"2025121512531857000_5.4.e007479.10","doi-asserted-by":"publisher","DOI":"10.1016\/S0959-8049(03)00489-1"},{"key":"2025121512531857000_5.4.e007479.11","doi-asserted-by":"crossref","first-page":"1993","DOI":"10.1016\/j.pain.2012.05.018","article-title":"Food, pain, and drugs: does it matter what pain patients eat?","volume":"153","author":"Bell","year":"2012","journal-title":"Pain"},{"key":"2025121512531857000_5.4.e007479.12","doi-asserted-by":"publisher","DOI":"10.1016\/j.pain.2007.08.021"},{"key":"2025121512531857000_5.4.e007479.13","doi-asserted-by":"publisher","DOI":"10.1097\/00042737-200109000-00004"},{"key":"2025121512531857000_5.4.e007479.14","doi-asserted-by":"publisher","DOI":"10.1016\/j.tins.2003.09.017"},{"key":"2025121512531857000_5.4.e007479.15","doi-asserted-by":"crossref","first-page":"e77828","DOI":"10.1371\/journal.pone.0077828","article-title":"A polyamine-deficient diet prevents oxaliplatin-induced acute cold and mechanical hypersensitivity in rats","volume":"8","author":"Ferrier","year":"2013","journal-title":"PloS ONE"},{"key":"2025121512531857000_5.4.e007479.16","doi-asserted-by":"publisher","DOI":"10.1016\/j.clnu.2013.09.019"},{"key":"2025121512531857000_5.4.e007479.17","doi-asserted-by":"publisher","DOI":"10.1042\/bst0310384"},{"key":"2025121512531857000_5.4.e007479.18","doi-asserted-by":"publisher","DOI":"10.1007\/s00726-007-0524-1"},{"key":"2025121512531857000_5.4.e007479.19","doi-asserted-by":"publisher","DOI":"10.1016\/j.biopha.2009.09.022"},{"key":"2025121512531857000_5.4.e007479.20","doi-asserted-by":"publisher","DOI":"10.1016\/j.pain.2004.12.010"},{"key":"2025121512531857000_5.4.e007479.21","doi-asserted-by":"publisher","DOI":"10.1016\/j.pain.2003.12.024"},{"key":"2025121512531857000_5.4.e007479.22","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0447.1983.tb09716.x"},{"key":"2025121512531857000_5.4.e007479.23","first-page":"773","article-title":"Biological significance of circulating polyamines in oncology","volume":"37","author":"Moulinoux","year":"1991","journal-title":"Cell Mol Biol"},{"key":"2025121512531857000_5.4.e007479.24","doi-asserted-by":"publisher","DOI":"10.1016\/j.nut.2007.12.014"},{"key":"2025121512531857000_5.4.e007479.25","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.323.7321.1123"},{"key":"2025121512531857000_5.4.e007479.26","unstructured":"Verbeke G . Linear mixed models for longitudinal data. New York: Springer, 2009."},{"key":"2025121512531857000_5.4.e007479.27","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbi.2008.08.010"},{"key":"2025121512531857000_5.4.e007479.28","doi-asserted-by":"publisher","DOI":"10.1634\/theoncologist.2010-0248"},{"key":"2025121512531857000_5.4.e007479.29","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2008.20.6771"},{"key":"2025121512531857000_5.4.e007479.30","first-page":"913848","article-title":"Healthcare costs and workloss burden of patients with chemotherapy-associated peripheral neuropathy in breast, ovarian, head and neck, and nonsmall cell lung cancer","volume":"2012","author":"Pike","year":"2012","journal-title":"Chemother Res Pr"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2014-007479","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T20:53:29Z","timestamp":1765832009000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2014-007479"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,4]]},"references-count":30,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2015,4,1]]},"published-print":{"date-parts":[[2015,4]]}},"alternative-id":["10.1136\/bmjopen-2014-007479"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2014-007479","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,4]]}}}