title: Use of an alpha lipoic, methylsulfonylmethane and bromelain dietary supplement (Opera®) for chemotherapy-induced peripheral neuropathy management, a prospective study.
abstract: Chemotherapy-induced peripheral neuropathy (CIPN) is a major clinical problem associated with a number of cytotoxic agents. OPERA®(GAMFARMA srl, Milan, Italy) is a new dietary supplement where α-lipoic acid, Boswellia Serrata, methylsulfonylmethane and bromelain are combined in a single capsule. The aim of this prospective study was to determine the efficacy and safety of OPERA®supplementation in a series of patients affected by CIPN. We selected 25 subjects with CIPN evolving during or after chemotherapy with potentially neurotoxic agents. Patients were enrolled at the first clinical manifestation of neuropathy. CIPN was assessed at the enrollment visit and subsequently repeated every 3 weeks until 12 weeks. Primary endpoint was the evaluation of changes of measured scores after 12 weeks of therapy compared to baseline evaluation. Secondary endpoints were the evaluation of neuropathy reduction at 12 weeks after beginning of therapy with OPERA®. Analysis of VAS data showed reduction in pain perceived by patients. According to NCI-CTC sensor and motor score, mISS scale and TNSc scale, both pain and both sensor and motor neuropathic impairment decreased after 12 weeks of treatments. Treatment with OPERA supplement was well tolerated; no increase in the toxicity profile of any of the therapeutic regimen that the patients were undergoing was reported. OPERA®was able to improve CIPN symptoms in a prospective series of patients treated with neurotoxic chemotherapy, with no significant toxicity or interaction. Prospective RCT in a selected patients' population is warranted to confirm its promising activity.
authors.affiliation: Department of Clinical and Experimental Biomedical Sciences, University of Florence, Viale Morgagni 85, 50134, Florence, Italy. isacco.desideri@unifi.it.
authors.forename: Isacco
authors.identifier: http://orcid.org/0000-0002-9880-8387
authors.initials: I
authors.lastname: Desideri
authors.affiliation: Department of Radiation Oncology, Azienda Ospedaliero-Universitaria Careggi, University of Florence, Florence, Italy.
authors.forename: Giulio
authors.initials: G
authors.lastname: Francolini
authors.affiliation: Department of Radiation Oncology, Azienda Ospedaliero-Universitaria Careggi, University of Florence, Florence, Italy.
authors.forename: Carlotta
authors.initials: C
authors.lastname: Becherini
authors.affiliation: Department of Radiation Oncology, Azienda Ospedaliero-Universitaria Careggi, University of Florence, Florence, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Terziani
authors.affiliation: Department of Radiation Oncology, Azienda Ospedaliero-Universitaria Careggi, University of Florence, Florence, Italy.
authors.forename: Camilla
authors.initials: C
authors.lastname: Delli Paoli
authors.affiliation: Department of Radiation Oncology, Azienda Ospedaliero-Universitaria Careggi, University of Florence, Florence, Italy.
authors.forename: Emanuela
authors.initials: E
authors.lastname: Olmetto
authors.affiliation: Department of Radiation Oncology, Azienda Ospedaliero-Universitaria Careggi, University of Florence, Florence, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Loi
authors.affiliation: Department of Radiation Oncology, Azienda Ospedaliero-Universitaria Careggi, University of Florence, Florence, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Perna
authors.affiliation: Department of Radiation Oncology, Azienda Ospedaliero-Universitaria Careggi, University of Florence, Florence, Italy.
authors.forename: Icro
authors.initials: I
authors.lastname: Meattini
authors.affiliation: Department of Radiation Oncology, Azienda Ospedaliero-Universitaria Careggi, University of Florence, Florence, Italy.
authors.forename: Vieri
authors.initials: V
authors.lastname: Scotti
authors.affiliation: Department of Radiation Oncology, Azienda Ospedaliero-Universitaria Careggi, University of Florence, Florence, Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Greto
authors.affiliation: Department of Radiation Oncology, Azienda Ospedaliero-Universitaria Careggi, University of Florence, Florence, Italy.
authors.forename: Pierluigi
authors.initials: P
authors.lastname: Bonomo
authors.affiliation: Department of Radiation Oncology, Azienda Ospedaliero-Universitaria Careggi, University of Florence, Florence, Italy.
authors.forename: Susanna
authors.initials: S
authors.lastname: Sulprizio
authors.affiliation: Department of Clinical and Experimental Biomedical Sciences, University of Florence, Viale Morgagni 85, 50134, Florence, Italy.
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Livi
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D001963:Bromelains / Q000008:administration & dosage*; D019587:Dietary Supplements; D004121:Dimethyl Sulfoxide / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy; D009498:Neurotoxins / Q000009:adverse effects / Q000627:therapeutic use; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced* / Q000188:drug therapy*; D011446:Prospective Studies; D013450:Sulfones / Q000008:administration & dosage*; D008063:Thioctic Acid / Q000008:administration & dosage*
chemical_list: D000970:Antineoplastic Agents; D009498:Neurotoxins; D013450:Sulfones; D008063:Thioctic Acid; D001963:Bromelains; C025910:dimethyl sulfone; D004121:Dimethyl Sulfoxide
keywords: Dietary supplement; Management; Neuropathy; Neurotoxic chemotherapy