Role of SAMITAL® in Prevention and Treatment of Oral Mucositis in Patients Treated With Chemo-radiation (CT/RT)for Head-and-neck Squamous Cell Carcinomas. A Double-blind, Phase 2 Placebo Controlled, Randomized Trial.
The purpose of this study is to: evaluate the activity of SAMITAL in reducing the incidence of severe mucositis in head-and-neck cancer patients undergoing chemo-radiotherapy. assess tolerability of SAMITAL and the impact on patients reported outcomes.
Role of SAMITAL in prevention and treatment of oral mucositis in patients treated with chemo-radiation (CT/RT)for head-and-neck squamous cell carcinomas. A double-blind, Phase 2 placebo controlled, randomized trial. - IOV-HN-1-2012 (ROSAM)
Role of SAMITAL in the Prevention and Treatment of Chemo-Radiotherapy-Induced Oral Mucositis in Head and Neck Carcinoma: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Trial (ROSAM).
作者: Elena Fasanaro ; Paola Del Bianco ; Elena Groff ; Antonella Riva ; Giovanna Petrangolini ; Fabio Busato ; Paola Stritoni ; Giovanni Scarzello ; Lucio Loreggian ; Gian Luca De Salvo
In patients affected by head and neck squamous cell carcinoma, the onset of severe oral mucositis is a decisive factor in completing concurrent chemo-radiotherapy, and few interventions have demonstrated a modest benefit. The primary aim of this clinical study was to evaluate the role of SAMITAL in reducing the incidence of severe mucositis induced by concurrent chemo-radiotherapy; the secondary aims were the tolerability and patient-reported quality of life measures.
Patients were randomized to receive SAMITAL granules for oral suspension of 20 mL, four-time daily or matching placebo in a 1:1 fashion using a stratified-block randomization scheme by disease site and type of chemotherapy. The SAMITAL/placebo was dispensed at the baseline visit and at each weekly visit following radiotherapy initiation. Patients were subjected to weekly endoscopic evaluations to assess the presence of mucositis. In addition, patient-reported outcomes were measured.
Among the 116 patients treated with a median total dose of 66 Gy, 59 were randomized to SAMITAL and 57 to placebo. Overall, the incidence of severe mucositis was 51.7%, with 45.8% in the SAMITAL and 57.9% in the placebo arm (OR = 0.6; 95% CI: 0.3-1.3). After chemo-radiotherapy, patients randomized to SAMITAL reported significantly lower xerostomia, coughing and swallowing scores and a better quality of life.
SAMITAL did not significantly reduce the incidence of severe mucositis in all studied populations. However, the lower rate of mucositis, together with a significantly better quality of life, suggested that a clinical benefit existed. This trial is registered with the EU Clinical Trials Register database, number 2012-002046-20, and with ClinicalTrials.gov, NCT01941992.
2022-11-01·European review for medical and pharmacological sciences
Administration of Samital® in children with oral mucositis: a feasibility study.
作者: D Massano ; A Paratella ; M C Affinita ; G L De Salvo ; G Petrangolini ; A Riva ; G Bisogno
SAMITAL®, a botanical drug containing three highly standardized extracts (Vaccinium myrtillus, Macleaya cordata and Echinacea angustifolia), has shown promising results in treating or preventing oral mucositis (OM) in adult patients, but it has not been fully investigated in children. In this study, we assessed the feasibility of SAMITAL administration in pediatric patients receiving anticancer treatment to prevent or treat OM, focusing on identifying an appropriate dose and evaluating safety and tolerability and palatability and treatment compliance.
PATIENTS AND METHODS:
We conducted an open-label, monocentric, prospective study on 18 children receiving anticancer therapy to prevent or treat OM.
No SAMITAL®-related side effects were observed or reported during the study; moreover, no systemic absorption of SAMITAL® metabolites was detected in the bloodstream. However, compliance to SAMITAL® was unsatisfactory and variable (from 2 to 100%), and patients reported low palatability (median taste of 4.8; range 1.0-8.0).
SAMITAL® administration appears to be safe in the pediatric population, as it is not absorbed in the bloodstream and does not cause any local or systemic side effects. However, the current formulation is only partially suitable for children, and future studies on SAMITAL® in children would need an adapted formulation to increase compliance.
2021-05-14·Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2区 · 医学
Medicinal plants used for the treatment of mucositis induced by oncotherapy: a systematic review.
2区 · 医学
作者: Patrícia Leão Castillo Eubank ; Lucas Guimaraes Abreu ; Ivana Povoa Violante ; Luiz Evaristo Ricci Volpato
This systematic review aimed to identify effective medicinal plants for the treatment of mucositis induced by oncotherapy.
The clinical question was the following: "Which medicinal plants are effective in the treatment of oral mucositis induced by cancer treatment?" (PubMed, Medline, Web of Science, Scopus, Lilacs, and SciELO). The keywords were the following: phytotherapy OR "herbal drug" OR "plant extract" OR plant OR "medicinal plant" OR pharmacognosy OR ethnobotany OR ethnomedicine OR ethnopharmacology OR "flower essences" OR "natural product" AND mucositis OR mucositides OR stomatitis OR stomatitides OR "oral ulcer" AND chemotherapy OR radiotherapy OR immunotherapy OR cancer OR neoplasm OR neoplasm OR tumor OR tumor. The inclusion criteria for the selection of articles were the type of study design (clinical trials) and the studied population (cancer patients presenting lesions of oral mucositis having undergone treatment with medicinal plants).
After evaluation of the works, 24 of 893 articles were selected. Matricaria chamomilla (chamomilla) presented promising results, such as a reduction in severity and lesion incidence with improved pain symptomatology. The plant extracts Isatis indigótica, Olea europaea, Calendula officinalis, A. digitatae, and M. sylvestris improved the lesions. Mucotrol™ and QRLYD herbal products improved the degree of severity of the lesions, while SAMITAL® and MUCOSYTE allowed for greater pain control.
The complementary treatment of oral mucositis in cancer patients, with analgesic and anti-inflammatory actions with lower side effects, is an alternative for healthcare professionals.