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Effectiveness of SAMITAL® for Management of Chemo/Radiotherapy-Induced Oral Mucositis in Patients with Cancer—a Systematic Review

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Abstract

Purpose of Review

Data from previous clinical trials indicate that SAMITAL® significantly decreases the severity of chemo/radiotherapy-induced oral mucositis (OM) in both adult and pediatric patients undergoing treatment for a wide range of malignancies. However, there is a lack of reliable evidence-backed literature for the extensive use of SAMITAL® for the management of chemo/radiotherapy-induced OM in cancer patients. This systematic review aimed to compare the available data on the efficacy of SAMITAL® for the prevention and management of oral mucositis in patients undergoing chemo/radiotherapy.

Recent Findings

Two studies found that SAMITAL® was effective in reducing OM in patients undergoing chemo/radiotherapy. In the other two studies, it was found that in cases where compliance was good, the incidence and severity of OM in patients undergoing chemo/radiotherapy were low.

Summary

Oral mucositis (OM) is one of the most common dose-limiting toxic effects of chemo/radiotherapy. Despite the predictability of OM and its negative implications on the treatment outcome of patients with cancer, an effective therapy for OM has long remained elusive. SAMITAL® is a combination of three highly standardized botanical drug extracts from Vaccinium myrtillus [bilberry], Macleaya cordata fruits, and Echinacea angustifolia roots. Six databases: PubMed, Scopus, Cochrane, Science Direct, Lilac, and Google scholar were searched without any date filter to obtain the relevant articles. A total of four articles met the eligibility criteria and were further processed for data extraction. Two studies found that SAMITAL® was effective in reducing OM in patients undergoing chemo/radiotherapy. In the other two studies, it was found that in cases where compliance was good, the incidence and severity of OM in patients undergoing chemo/radiotherapy were low. Based on the scope of this review, we concluded that SAMITAL® can be used as an effective therapeutic and prophylactic agent to reduce or prevent the degree of OM in patients undergoing chemo/radiotherapy.

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References

Papers of particular interest, published recently, have been highlighted as: • Of importance

  1. Brown TJ, Gupta A. Management of cancer therapy-associated oral mucositis. JCO Oncol Pract. 2020;16:103–9.

    Article  PubMed  Google Scholar 

  2. Poulopoulos A, Papadopoulos P, Andreadis D. Chemotherapy: oral side effects and dental interventions—a review of the literature. Stomatological Dis Sci. 2017;1:35–49.

    Google Scholar 

  3. Ps SK, Balan A, Sankar A, Bose T. Radiation induced oral mucositis. Indian J Palliat Care. 2009;15:95–102.

    Article  PubMed  PubMed Central  Google Scholar 

  4. Cinausero M, Aprile G, Ermacora P, Basile D, Vitale MG, Fanotto V, Parisi G, Calvetti L, Sonis ST. New frontiers in the pathobiology and treatment of cancer regimen-related mucosal injury. Front Pharmacol. 2017;8:354.

    Article  PubMed  PubMed Central  Google Scholar 

  5. Maria OM, Eliopoulos N, Muanza T. Radiation-induced oral mucositis. Front. Oncol. 2017;7:89.

    Google Scholar 

  6. Juan CA, Pérez de la Lastra JM, Plou FJ, Pérez-Lebeña E. The chemistry of reactive oxygen species (ROS) revisited: outlining their role in biological macromolecules (DNA, lipids and proteins) and induced pathologies. Int J Mol Sci. 2021. https://doi.org/10.3390/ijms22094642.

    Article  PubMed  PubMed Central  Google Scholar 

  7. Galeaz C, Totis C, Bisio A. Radiation resistance: a matter of transcription factors. Front Oncol. 2021;11: 662840.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  8. Kany S, Vollrath JT, Relja B (2019) Cytokines in inflammatory disease. Int J Mol Sci.https://doi.org/10.3390/ijms20236008

  9. Chen L, Deng H, Cui H, Fang J, Zuo Z, Deng J, Li Y, Wang X, Zhao L. Inflammatory responses and inflammation-associated diseases in organs. Oncotarget. 2018;9:7204–18.

    Article  PubMed  Google Scholar 

  10. Pulito C, Cristaudo A, Porta CL, Zapperi S, Blandino G, Morrone A, Strano S. Oral mucositis: the hidden side of cancer therapy. J Exp Clin Cancer Res. 2020;39:210.

    Article  PubMed  PubMed Central  Google Scholar 

  11. Massano D, Paratella A, Affinita MC, De Salvo GL, Petrangolini G, Riva A, Bisogno G (2022) Administration of Samital® in children with oral mucositis: a feasibility study. Eur Rev Med Pharmacol Sci 26:8576–8581. This study assessed the feasibility of SAMITAL® administration in pediatric patients receiving anticancer treatment to prevent or treat oral mucositis.

  12. Bertoglio JC, Calderón S, Lesina B, Pilleux L, Morazzoni P, Riva A, Bombardelli E, Ronchi M, Cabri W, Petrangolini G (2013) Effect of SAMITAL® in the treatment of chemotherapy-induced mucositis in adult oncohematological patients. Future Oncol 9:1727–1732. This study assessed the efficacy and safety of SAMITAL® in reducing mucositis in patients undergoing treatment for hematological malignancies.

  13. Fasanaro E, Del Bianco P, Groff E, Riva A, Petrangolini G, Busato F, Stritoni P, Scarzello G, Loreggian L, De Salvo GL (2022) 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). Cancers. https://doi.org/10.3390/cancers14246192. This trial evaluated the role of SAMITAL® in reducing the incidence of severe mucositis induced by concurrent chemo-radiotherapy.

  14. Pawar D, Neve RS, Kalgane S, Riva A, Bombardelli E, Ronchi M, Petrangolini G, Morazzoni P (2013) SAMITAL® improves chemo/radiotherapy-induced oral mucositis in patients with head and neck cancer: results of a randomized, placebo-controlled, single-blind Phase II study. Support Care Cancer 21:827–834. This trial investigated the safety and efficacy of SAMITAL® in the treatment of chemo/radiotherapy-induced oral mucositis (OM) in patients with head and neck cancer.

  15. Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372: n71.

    Article  PubMed  PubMed Central  Google Scholar 

  16. Risk of bias 2 (RoB 2) tool. https://methods.cochrane.org/risk-bias-2. Accessed 2 Mar 2023

  17. ROBINS-I tool. https://methods.cochrane.org/methods-cochrane/robins-i-tool. Accessed 2 Mar 2023

  18. Agency for Healthcare Research and Quality (AHRQ). https://www.ahrq.gov/. Accessed 2 Mar 2023

  19. Jairam V, Lee V, Park HS, Thomas CR, Melnick ER, Gross CP, Presley CJ, Adelson KB, Yu JB. Treatment-related complications of systemic therapy and radiotherapy. JAMA Oncol. 2019;5:1028–35.

    Article  PubMed  PubMed Central  Google Scholar 

  20. Liu Y-P, Zheng C-C, Huang Y-N, He M-L, Xu WW. Li B (2021) Molecular mechanisms of chemo- and radiotherapy resistance and the potential implications for cancer treatment. MedComm. 2020;2:315–40.

    Article  Google Scholar 

  21. Salas-Vega S, Iliopoulos O, Mossialos E. Assessment of overall survival, quality of life, and safety benefits associated with new cancer medicines. JAMA Oncol. 2017;3:382–90.

    Article  PubMed  Google Scholar 

  22. Eubank PLC, Abreu LG, Violante IP, Volpato LER. Medicinal plants used for the treatment of mucositis induced by oncotherapy: a systematic review. Support Care Cancer. 2021;29:6981–93.

    Article  PubMed  Google Scholar 

  23. Bertoglio JC, Folatre I, Bombardelli E, Riva A, Morazzoni P, Ronchi M, Petrangolini G. Management of gastrointestinal mucositis due to cancer therapies in pediatric patients: results of a case series with SAMITAL(®). Future Oncol. 2012;8:1481–6.

    Article  PubMed  CAS  Google Scholar 

  24. Vadhan-Raj S, Goldberg JD, Perales M-A, Berger DP, van den Brink MRM. Clinical applications of palifermin: amelioration of oral mucositis and other potential indications. J Cell Mol Med. 2013;17:1371–84.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

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Correspondence to Subhashree Mohapatra.

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Mohandas, R., Mohapatra, S. Effectiveness of SAMITAL® for Management of Chemo/Radiotherapy-Induced Oral Mucositis in Patients with Cancer—a Systematic Review. Curr Oral Health Rep 10, 175–183 (2023). https://doi.org/10.1007/s40496-023-00353-0

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