Natural Medicine Journal Oncology Supplement: Vol 9 No 111

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OPERA Supplementation for Chemotherapy-Induced Peripheral Neuropathy Positive results, but how significant? REFERENCE

Desideri I, Francolini G, Becherini C, et al. Use of alpha lipoic, methylsulfonylmethane and bromelain dietary supplement (OPERA) for chemotherapy-induced peripheral neuropathy management, a prospective study. Med Oncol. 2017;34(3):46. OBJECTIVE

To determine the efficacy and safety of OPERA supplementation (240 mg alpha lipoic acid, 40 mg Boswellia serrata, 20 mg bromelain, and 200 mg methylsulfonylmethane [MSM]) in a series of patients with chemotherapyinduced peripheral neuropathy (CIPN). DESIGN

Prospective intervention study PARTICIPANTS

Twenty-five Caucasian adults with CIPN during or after chemotherapy with potentially neurotoxic agents; patients were enrolled in the study at the first clinical manifestation of neuropathy. The diagnosis of CIPN was based on the National Cancer Institute-Common Toxicity Criteria for Adverse Event (NCICTCAE) v4.0 grade of ≥1 for sensory neuropathy, with at least a report of paresthesia of fingers or toes (a criterion for grade 1). Inclusion criteria were as follows: 18 years or older; Karnofsky performance score >70; treatment with one of the following agents: paclitaxel, docetaxel, nab-paclitaxel, oxaplatin, cisplatin, carboplatin, vinorelbine, vincristine, etoposide, eribulin mesylate; CIPN that evolved after or during standard chemotherapy. Twenty-three patients (92%) received chemotherapy with a neurotoxic agent at

enrollment, while 2 patients (8%) had completed chemotherapy with a neurotoxic drug. INTERVENTION

All patients were required to take an OPERA capsule once a day, without regard to administration of food. STUDY PARAMETERS ASSESSED

Chemotherapy-induced peripheral neuropathy was assessed at the enrollment visit and repeated every 3 weeks until 12 weeks, using the following: the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) v3.0, sensory and motor neuropathy score; the Total Neuropathy Score clinical version (TNSc); and the modified Inflammatory Neuropathy Cause and Treatment (INCAT) group sensory summary score (mISS). The Visual Analog Scale (VAS) for pain was used to assess pain intensity. PRIMARY OUTCOME MEASURES

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. KEY FINDINGS

OPERA dietary supplement was able to improve CIPN symptoms in a prospective case series of patients treated with neurotoxic chemotherapy, with no significant toxicity or interaction. In addition, no worsening of pain or CIPN symptoms was reported with use of OPERA. There was no statistical analysis performed for this study.

Miranda LaBant, ND PRACTICE IMPLICATIONS Chemotherapy-induced peripheral neuropathy describes damage to the peripheral nervous system incurred by a patient who has received a neurotoxic chemotherapeutic agent. It is a frequent dose-limiting side effect for cancer patients treated with platinumderived compounds, vinca alkaloids, taxanes, and the proteasome inhibitors.1 Neurotoxicity incidence varies depending on the agent used and cumulative dose, with rates ranging from 19% to more than 85% in patients treated with multiple agents.2 A recent metaanalysis showed a CIPN prevalence of 68.1% (95% CI: 57.7-78.4) within the first month post-chemotherapy, 60.0% at 3 months, and 30.0% at 6 months or later.3 No reliably effective treatment has been established to prevent or treat CIPN symptoms. Duloxetine has provided only modest benefit and has associated side effects and a high dropout rate. The 2014 American Society of Clinical Oncology CIPN guideline gives a moderate recommendation for treatment with duloxetine, and recommends further research in this area.4 New safe and effective treatments are needed. Increased interest in CIPN has included the investigation of several nonpharmaceutical interventions. This study evaluates the dietary supplement OPERA to treat CIPN. While the authors established the efficacy and safety of OPERA for CIPN, there are several restrictive variables. There is limited and conflicting evidence for the components of OPERA. Alpha-lipoic acid has been shown to boost levels of glutathione and support healthy nerve tissue and blood sugar levels.5 Boswellia serrata is a potent anti-inflammatory herb and helps to balance the activity of 5-lipoxygenase (LOX) and support a healthy inflammatory response.6 Methylsulfonylmethane has been shown to reduce C-fiber nerve conduction,7 which is essential for effective pain control. It also has chemopreventive properties and anti-inflammatory activities.8,9 The components of OPERA may work synergistically to improve the symptoms of CIPN because they