Introduction
Oral mucositis is a serious and common complication of chemotherapy in patients with cancer, for which definitive treatments are lacking. Effective management is therefore crucial. Salvia officinalis L. possesses antioxidant and anti-inflammatory properties and may have preventive effects on this complication. This randomised, double-blind, placebo-controlled clinical trial evaluated the effectiveness of Salvizan gel (containing 28% hydroalcoholic extract of S. officinalis) in preventing chemotherapy-induced oral mucositis.
Methods
Thirty-eight patients with gastrointestinal cancers were randomised to the Salvizan gel group (n = 18) or placebo (n = 20). The severity of oral mucositis was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and World Health Organization criteria, and mucositis-related pain was measured with a visual analogue scale. Secondary outcomes included xerostomia and ageusia, as well as changes in food intake type (solid, liquid, semisolid, or inability). Assessments were performed weekly for four weeks. Data were analysed with SPSS version 26.
Results
Salvizan gel reduced the severity of oral mucositis according to CTCAE v5.0 and World Health Organization criteria during weeks 1 and 3. It also significantly reduced mucositis-related pain in week 1 and showed a notable reduction in week 2. Patients in the Salvizan group were better able to consume solid foods, and xerostomia associated with mucositis was significantly lower in this group. There was no significant effect of Salvizan gel on ageusia.
Conclusion
Salvizan gel demonstrates short-term protective effects against chemotherapy-induced oral mucositis in patients with cancer and may be considered as an adjunct in treatment protocols for this complication. However, clinical studies with larger sample sizes are strongly recommended in this regard.
IRCT code
IRCT20211029052907N4
Ethical code
IR.ZUMS.REC.1403.088
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