Abstract
Objective: Oral mucositis is a major complication of cytotoxic chemotherapy and radiotherapy associated with significant morbidity, pain, odynophagia, dysgeusia and subsequent dehydration and malnutrition, and effective prophylaxis and/or treatment of this condition is essential. The currently available palliative treatment shows improvement only in patients with mild to moderate mucositis. The primary aim of this study was to compare the clinical efficacy of MF 5232 (Mucotrol™), a concentrated oral polyherbal gel wafer formulation, with placebo in the management of chemoradiation-induced mucositis in cancer patients.
Patients and design: In this randomised, double-blind, pilot study a total of 30 patients of either sex with chemoradiation-induced oral mucositis were randomised to receive MF 5232 (n = 15) or a matching placebo (n = 15) after food three times a day for 7–10 days. Patients were evaluated using validated and standardised scoring systems at baseline and after 7–10 days of treatment.
Results: There were 11 evaluable patients in each treatment group. There was a significant reduction in mean mucositis scores with MF 5232 as follows: WHO (from 3.0 to 1.8), Radiation Therapy Oncology Group (gross score: from 2.8 to 1.8; functional score: from 2.9 to 1.0), and Objective Scoring System (ulceration score: from 7.4 to 4.4; erythema score: from 13.7 to 7.0). There were no significant changes in scores for placebo recipients. The treatments were well tolerated, with the exception of two patients in the treatment group who reported a burning sensation in the mouth after dissolving the wafer.
Conclusion: This pilot study provided positive evidence for the efficacy of MF 5232 therapy in chemoradiation-induced mucositis. This was probably a result of its local analgesic, antioxidant and immunomodulatory activity and wound-healing properties. Further in-depth analysis in a larger number of patients is required to confirm these positive results.
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References
Rankin, KV, Jones DL, eds. Oral health in cancer therapy. A guide for healthcare professionals. Austin (TX): DOEP, Texas Cancer Council, 1999: 1–48
Dose AM. The symptom experience of mucositis, stomatitis and xerostomia. Semin Oncol Nurs 1995; 11: 248–55
Naidu MU, Ramana GV, Rani PU, et al. Chemotherapy-induced and/or radiation therapy-induced oral mucositis-complicating the treatment of cancer. Neoplasia 2004; 6 (5): 423–30
Zlotolow IM. General considerations in prevention and treatment of oral manifestation of cancer therapies. In: Bergt AP, Weissman DE, editors. Principles and practice of supportive oncology. Philadelphia (PA): Lippincott Raven, 1998: 237
Kostler WJ, Hejna M, Wenzel C, et al. Oral mucositis complicating chemotherapy and/or radiotherapy: options for prevention and treatment. CA Cancer J Clin 2001; 51: 290–315
Berger AM, Kilroy TJ. Oral complications. In: DeVita Jr VJ, Hellmen S, Rosenberg SA, editors. Principles and practice of oncology. 5th ed. Philadelphia (PA): Lippincott Raven, 1997: 2714
Wilkes JD. Prevention and treatment of oral mucositis following cancer therapy. Semin Oncol 1998; 25: 538–51
Sonis ST, Eilers JP, Epstein JB, et al. Validation of a new scoring system for the assessment of clinical trial research of oral mucositis induced by radiation or chemotherapy. Cancer 1999 May 15; 85 (10): 2103–13
Loprinzi CL, Ghosh C, Camoriano J, et al. Schaefer PL, Novotny PJ, Gerstner JB, et al. Phase III controlled evaluation of sucralfate to alleviate stomatitis in patients receiving fluorouracil based chemotherapy. J Clin Oncol 1997; 3: 1235–8
LeVeque FG, Parzuchowski JB, Farinacci GC, et al. Clinical evaluation of MGI 209 an anesthetic film forming agent for relief from painful oral ulcers associated with chemotherapy. J Clin Oncol 1992; 12: 1963–8
Menachem O. A randomized controlled clinical trial of the homeopathic medication Traumeel SR in the treatment of chemotherapy induced stomatitis in children undergoing stem cell transplantation. Cancer 2001; 92: 684–90
Jayashree G, Kurup Muraleedhara G, Sudarslal S, et al. Antioxidant activity of Centella asiatica on lymphoma-bearing mice. Fitoterapia 2003 Jul; 74 (5): 431–4
Jayathirtha MG, Mishra SH. Preliminary immunomodulatory activities of methanol extracts of Eclipta alba and Centella asiatica. Phytomedicine 2004; 11 (4): 361–5
Acknowledgements
The authors acknowledge Belcher Pharmaceuticals, Inc. (wholly owned subsidiary of GeoPharma, Inc.) Largo, FL, USA, for funding the study, and the staff of the Department of Radiation Oncology, in particular all residents, radiation technologists and radiation physicists for their assistance with this study. The authors have no potential conflicts of interest that are directly relevant to the contents of this article.
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Naidu, M.U.R., Ramana, G.V., Ratnam, S.V. et al. A Randomised, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy of MF 5232 (Mucotrol™), a Concentrated Oral Gel Wafer, in the Treatment of Oral Mucositis. Drugs R D 6, 291–298 (2005). https://doi.org/10.2165/00126839-200506050-00005
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DOI: https://doi.org/10.2165/00126839-200506050-00005