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

Abstract

BackgroundNeoplasms 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 hepatoprotective properties. Lithothamnium calcareum (Lithothamnium) is a calcified seaweed that possesses remineralization properties and the ability to maintain homeostasis.AimIn 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.MethodsTwelve 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.ResultsGPS, 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<0.05) while fatigue improved at weeks 8 and 10 (all P<0.01).ConclusionWe found that chemotherapy, combined with Desmodium and Lithothamnium, improved pain and fatigue in head and neck cancer patients, although we cannot confirm if this was due to Desmodium and Lithothamnium or chemotherapy. The improvement in pain and fatigue was supported by the ECOG performance status remaining stable with the highest score being equal to 2 throughout the study and a trend towards an improvement in GPS performance status and albumin levels.

Desmodium adscendens (Sw.) DC.: A magnificent plant with biological and pharmacological properties

“…In 2019, a single‐arm study investigated the therapeutic potential of Desmovit®, a medical device containing 300 mg of DA leaves and 50 mg of Lithotamnium calcareum (a red marine algae rich in calcium and magnesium) in patients with head and neck cancer treated with standard chemotherapy (paclitaxel 75 mg/m 2 plus carboplatin or methotrexate 40 mg/m 2 ) (Imperatori et al., 2018). Twelve patients received an intravenous infusion of paclitaxel or methotrexate and a medical device containing 300 mg of DA leaves and 50 mg of L. calcareum .…”

“…For DA, different studies have been conducted providing evidence of its medical use, essentially derived and based on ethnobotanical use in Africa and India. Rational evidence originates from different preclinical in vitro and in vivo research on DA (Ma et al., 2011; Rastogi et al., 2011) and one clinical trial (Imperatori et al., 2018). These proofs, although of a certain value, cannot clearly and definitely justify the use of DA in humans, lacking a large, randomized, placebo‐controlled study.…”