Studio osservazionale prospettico volto a valutare la ridotta prevalenza di neuropatia sensoriale periferica in pazienti affetti da neoplasia solida metastatica in trattamento con taxani

Torn (taxane opera reducing neurotoxicity)

di R. Berardi: Università Politecnica delle Marche, Clinica Oncologica, Ospedali Riuniti Ancona

Obiettivi:Lo studio si prefigge di raggiungere i seguenti obiettivi:

Primario:

Dimostrare una prevalenza di neuropatia sensoriale periferica di grado 2-4 del 20% in pazienti in trattamento con schema chemioterapico a base di taxani per neoplasia solida metastatica o localmente avanzata inoperabile ed in terapia integrativa con Opera, utilizzato come da pratica clinica.

Secondari:

  • Valutare l’associazione tra prevalenza di neuropatia sensoriale periferica e caratteristiche del paziente
  • Valutare l’associazione tra prevalenza di NSP e durata del trattamento
  • Valutare la Neuroprotezione (durata della NSP, prevalenza di riduzione del dosaggio e/o del prolungamento dell’intervallo di tempo tra un ciclo e l’altro a causa della NSP, prevalenza di interruzione del trattamento con taxani a causa di NSP)
  • Profilo di sicurezza di Opera
  • Valutare la qualità di vita con il questionario EORTC QLQ-C30

A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF OPERA® FOR REDUCING TREATMENT DISCONTINUATION IN RESECTED COLORECTAL CANCER RECEIVING OXALIPLATIN-BASED ADJUVANT CHEMOTHERAPY

A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF OPERA® FOR REDUCING TREATMENT DISCONTINUATION IN RESECTED COLORECTAL CANCER RECEIVING OXALIPLATIN-BASED ADJUVANT CHEMOTHERAPY

di Prof. S. Cascinu – Division of Oncology, University Hospital of Modena

Study Objective(s):

Primary: To evaluate the efficacy of Opera® in preventing oxaliplatin dose reductions, cycles delays and patient withdraw in patients receiving oxaliplatin-containing adjuvant chemotherapy for resected colorectal cancer

Secondary: To evaluate the impact of Opera® on treatment efficacy.

Sottoposto al comitato etico.

USE OF AN ALPHA LIPOIC, METHYLSULFONYLMETHANE AND BROMELAIN DIETARY SUPPLEMENT (OPERA) FOR CHEMOTHERAPY-INDUCED PERIPHERAL NEUROPATHY MANAGEMENT, A PROSPECTIVE STUDY

Pubblicato su medical oncology march 2017, 34:46

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.

Fontewww.springer.com

OPERA SI DIMOSTRA EFFICACE NEL TRATTAMENTO DELLE POLINEUROPATIE

Poster presentato al congresso nazionale di neurologia (sin) a venezia 2017

Observational study to assess the efficacy of “Opera” in reducing polyneuropatic symptoms

E.Pucci (1) , S.Cristina (1), G. Scarì (2) , R. Galante (3) (1) Department of Brain and Behavior Sciences, University of Pavia. IRCCS “C. Mondino” Pavia. (2) Department of Biosciences, University of Milan (3) GamFarma Srl. Milan.

ABSTRACT

Aims

>Polyneuropathy is a very disabling disease of the peripheral nerves but there are few effective treatments often associated with side effects such as dizziness and drowsiness that can worsen the quality of life of patients. The antioxidant alpha-lipoic acid has proven useful in reducing pain.

The aim of this study is to demonstrate benefits, safety and tolerability of Opera, a nutritional supplement, containing alpha-lipoic acid associated with boswellia serrata, methylsulfonylmethane and bromelain with anti-inflammatory, analgesic and anti-edema activity.

Opera is developed with the innovative system Actibox “programmed release capsules”, set up to carry and release substances in the target organs in typical pH lowering conditions of an inflammatory status. Materials and

Methods

Between November 2015 and April 2016, thirty consecutive adult patients attending at Neurological Institute C. Mondino with longer polyneuropathy, were treated with Opera, once a day, for 2 months. Patients were evaluated at baseline and after 2 months using Visual Analogue Scale (VAS) and Douleur Neuropathique en 4 Questions ( DN4 ): data relative to efficacy and tolerability were collected. Patient’s characteristics: 17 male, 13 female; median age 53 (range 38-72); diagnosis: diabetes 11, oncological disease 6, hepatitis C 2, post-herpes neuropathy 4, and compressive radiculopathy 7. At the baseline, average number of pain attacks was 5,2 (range 4-7), medium VAS 6,7 (range 5-8) and medium DN4 6,1 (range 4-8).

Results

Opera was well tolerated: in a numerical scale from 1 to 10 the average score was 8 (range 7-10); the compliance of patients was optimal, no side effect related to product were reported and no weight gain in patients occurred. Regarding efficacy, at the end of treatment, all parameters analyzed were significantly improved (p<0.0001): average number of pain attacks was 1,2 (range 0-2), median VAS 1,7 (range 0-4) and median DN4 1,4 (range 0-3). Improvements were observed in all patients regardless of disease.

Conclusions

Our study has clearly demonstrated the benefits, safety, and good tolerability of Opera in polyneuropathy treatment, regardless of the underlying disease and the use of this medication should be taken in consideration as a good practice in this setting of patients. Data from our study are encouraging to be confirmed by further investigations.