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.

开始日期2012-12-01

申办/合作机构

Istituto Oncologico Veneto

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100 项与 Samital 相关的临床结果

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100 项与 Samital 相关的转化医学

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100 项与 Samital 相关的专利（医药）

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项与 Samital 相关的文献（医药）

2022-11-01·European review for medical and pharmacological sciences

Administration of Samital® in children with oral mucositis: a feasibility study.

Article

作者: Paratella, A ; Bisogno, G ; De Salvo, G L ; Massano, D ; Petrangolini, G ; Riva, A ; Affinita, M C

OBJECTIVESAMITAL®, 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 METHODSWe conducted an open-label, monocentric, prospective study on 18 children receiving anticancer therapy to prevent or treat OM.RESULTSNo 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).CONCLUSIONSSAMITAL® 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.

2013-11-30·Future Oncology4区 · 医学

Effect of SAMITAL ^® in the Treatment of Chemotherapy-Induced Mucositis in Adult Oncohematological Patients

4区 · 医学

Article

作者: Bombardelli, Ezio ; Riva, Antonella ; Calderón, Susana ; Pilleux, Lilian ; Ronchi, Massimo ; Lesina, Blaz ; Cabri, Walter ; Bertoglio, Juan Carlos ; Morazzoni, Paolo ; Petrangolini, Giovanna

Aim: We sought to evaluate the efficacy and safety of SAMITAL® (Indena SpA, Milan, Italy), a highly standardized botanical formulation, in reducing mucositis in patients undergoing treatment for hematological malignancies. Patients & methods: In this observational, uncontrolled study, a total of 25 consecutively enrolled patients (19 males, aged 18–74 years) with chemotherapy-induced mucositis were compassionately treated orally with SAMITAL (three to four times per day) for 4–22 days per cycle. Results: Patients demonstrated clinically relevant reductions in WHO mucositis grade with a reduction in pain, mucosal erosions, bleeding, dysphagia/feeding impairment and improvements in quality of life. SAMITAL was well tolerated and no local or systemic pharmacological, allergic, toxic or synergistic/antagonistic side effects were reported. Of note, SAMITAL also showed efficacy when administered prophylactically. Conclusion: These results add weight to previous experiences with SAMITAL. However, randomized, placebo-controlled clinical trials will need to confirm the suitability of SAMITAL for use in the treatment of mucositis.

2013-11-30·Future Oncology4区 · 医学

SAMITAL ^® : A New Botanical Drug for the Treatment of Mucositis Induced by Oncological Therapies

4区 · 医学

Review

作者: Ronchi, Massimo ; Morazzoni, Paolo ; Cabri, Walter ; Bombardelli, Ezio ; Petrangolini, Giovanna ; Riva, Antonella

SAMITAL(®) (Indena SpA, Milan, Italy) is a new multicomponent and multiacting botanical formulation rationally designed for the relief of oral mucositis induced by chemotherapy and/or radiotherapy in oncological patients. Each of the individual botanical constituents of SAMITAL-standardized extracts of Vaccinium myrtillus, Macleaya cordata and Echinacea angustifolia have a long history of clinical use that corroborates their safety and activity in SAMITAL. A number of pilot trials in oncological patients demonstrated that SAMITAL has good clinical efficacy and tolerability as evidenced by its significant effects in terms of reduction of mucositis, pain and a general improvement in patient quality of life. Importantly, the use of this botanical formulation had the added benefit that patients were able to complete their chemotherapy/radiotherapy regimen. Phase II trials with SAMITAL as part of an overall clinical development program are currently ongoing in Italy and are planned in the USA.

100 项与 Samital 相关的药物交易

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