Abstract

This study was designed to determine the effect of Calendula officinalis flowers extract mouthwash as oral gel on radiation-induced oropharyngeal mucositis (OM) in patients with head-and-neck cancer. Forty patients with neck and head cancers under radiotherapy or concurrent chemoradiotherapy protocols were randomly assigned to receive either 2% calendula extract mouthwash or placebo (20 patients in each group). Patients were treated with telecobalt radiotherapy at conventional fractionation (200 cGy/fraction, five fractions weekly, 30–35 fractions within 4–7 weeks). The oropharyngeal mucositis was evaluated by two clinical investigators (a radiation oncologist and a dentist), using the oral mucositis assessment scale (OMAS). Trying to find out the possible mechanism of action of the treatment, total antioxidant, polyphenol and flavonoid contents, and quercetin concentration of the mouth wash were measured. Calendula mouthwash significantly decreased the intensity of OM compared to placebo at week 2 (score: 5.5 vs. 6.8, p = 0.019), week 3 (score: 8.25 vs. 10.95, p < 0.0001) and week 6 (score: 11.4 vs. 13.35, p = 0.031). Total antioxidant, polyphenol and flavonoid contents and quercetin concentration of the 2% extract were 2353.4 ± 56.5 μM, 313.40 ± 6.52 mg/g, 76.66 ± 23.24 mg/g, and 19.41 ± 4.34 mg/l, respectively. Calendula extract gel could be effective on decreasing the intensity of radiotherapy- induced OM during the treatment and antioxidant capacity may be partly responsible for the effect.

Highlights

  • One of the most commonly perturbing adverse effect of radiotherapy (RT) in head and neck cancers is oropharyngeal mucositis (OM) which comprises the main dose limiting side effect [1]

  • None of the patients in calendula group underwent medication for OM severity and radiotherapy was not ceased for this reason

  • OM intensity was measured according to oral mucositis assessment scale (OMAS) scores at the end of each week for both calendula and placebo groups

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Summary

Introduction

One of the most commonly perturbing adverse effect of radiotherapy (RT) in head and neck cancers is oropharyngeal mucositis (OM) which comprises the main dose limiting side effect [1]. Triottie et al stated that the incidence of radiotherapy induced OM in head and neck cancer patients is more than 80% [3]. According to the mentioned properties for calendula officinalis such as anti-inflammatory, anti bacterial, and antioxidant effects and considering the pathobiology of OM, it would be interesting to evaluate its effect on radiation-induced OM. Based on these concepts; this study was designed to determine the effect of calendula flowers extract mouthwash as gel formulation in the OM of head and neck cancers radiotherapy

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