Feasibility single-arm study of a medical device containing Desmodium adscendens and Lithothamnium calcareum combined with chemotherapy in head and neck cancer patients

Luca Imperatori,1 Damiano Giardini,2 Gino Latini,2 Giuseppe Migliori,2 Claudio Blasi,3 Feisal Bunkheila,3 Cesare Breschi,4 Rodolfo Mattioli,1 Silvia Pelliccioni,1 Carmen Laurino,5 Maria Vadalà,5 Beniamino Palmieri,5 Tommaso Iannitti6 1UOC Oncologia Medica Azienda Ospedaliera Ospedali Riuniti Marche Nord, Fano, Italy; 2UOC Otorinolaringoiatria Az. Ospedaliera Ospedali Riuniti Marche Nord, Fano, Italy; 3UOC Radioterapia Az. Ospedaliera Ospedali Riuniti Marche Nord, Fano, Italy; 4UOC Anestesia e Rianimazione Az. Ospedaliera Ospedali Riuniti Marche Nord, Fano, Italy; 5Department of General Surgery and Surgical Specialties, Surgical Clinic, University of Modena and Reggio Emilia Medical School, Modena, Italy; 6KWS BioTest, Marine View Office Park, Portishead, Somerset, UK Background: Neoplasms of the head and neck represent approximately 5% of cancers and they require complex multidisciplinary clinical management. Desmodium adscendens (Desmodium) is a plant that possesses anti-allergic, antioxidant and hepato-protective properties. Lithothamnium calcareum (Lithothamnium) is a calcified seaweed that possesses remineralization properties and the ability to maintain homeostasis.Aim: In this single-arm study, we investigated the efficacy of a combination therapy based on Desmovit® which contains Desmodium and Lithothamnium, and chemotherapy in patients with head and neck cancer.Methods: Twelve patients with histological or cytological diagnosis of stage IV head and neck cancer were enrolled in this study that was approved by the ethics committee of the Unità Operativa Complessa (UOC) di Oncologia Medica Azienda Ospedaliera Ospedali Riuniti Marche Nord and followed the Declaration of Helsinki guidelines. The patients were monitored by investigation of the performance status according to the Glasgow Prognostic Score (GPS), which evaluates the plasma level of C-reactive protein and albumin levels, and the Eastern Cooperative Oncology Group (ECOG) examination. Pain and fatigue were also monitored using the visual analog scale and visual analog fatigue scale, respectively. All the above parameters were assessed biweekly to week 10.Results: GPS, ECOG, and albumin remained stable throughout the study with a trend towards a decrease in GPS and albumin at week 10 post-treatment. Pain significantly improved at week 8 (P