Sumac-rose water mouthwash versus benzydamine to prevent radiation-induced oral mucositis in head and neck cancers: a phase II randomized trial.

BACKGROUND: Radiation-induced oral mucositis (OM) largely impairs the quality of life (QoL) of patients with head and neck cancer (HNC). Few choices with limited efficacy are available to prevent this adverse effect. This randomized trial was conducted to compare the efficacy of benzydamine (standard) and a new combination (sumac and rose water) in preventing radiation-induced OM. METHODS: This was a phase II, triple-blind, active-controlled, randomized trial. The primary endpoint was OM, and the secondary endpoints were oral pain and QoL. Besides, the possible variables defining the outcomes were analyzed using the chi-squared test (univariate analysis) and binomial regression model (multivariate analysis). RESULTS: Sumac-rose group had fewer high-grade OM (33% vs. 63%, odds ratio [OR] 0.28, 95% confidence interval [CI 95%] 0.08-0.93, P = 0.03) and better QoL (P < 0.05). Multivariate analysis confirmed these findings. Sumac-rose rinsing could also postpone the start of oral pain (hazard ratio [HR] 0.02, CI 95% 0.001-0.32, P = 0.001) and high-grade OM (HR 0.28, P = 0.03) compared with benzydamine. CONCLUSIONS: The sumac-rose group had a lower OM rate and grade and higher QoL than the benzydamine group. In addition, the experimental group developed high-grade OM and oral pain later during the radiotherapy course. Further studies need to be conducted to assess the role of sumac and rose water in reducing grade 3-4 mucositis in patients who undergo chemoradiation for head and neck cancer.

Effect of Honey-Lemon Spray Versus Benzydamine Hydrochloride Spray on Radiation-Induced Acute Oral Mucositis in Head and Neck Cancer Patients: A Pilot, Randomized, Double-Blind, Active-Controlled Clinical Trial.

Introduction: Oral mucositis (OM) is the most prevalent side effect in patients with head and neck cancer (HNC). It causes an obvious decrease in quality of life (QoL) in these patients, so different medications have been recommended for OM, however, without optimal response. This randomized trial aimed to assess the effects of a honey-lemon spray compared with benzydamine hydrochloride in prevention of radiation-induced OM in patients with HNC. Materials and Methods: Forty-six patients with HNC received external beam radiotherapy for 5 days per week. Patients were randomized to treatment with either benzydamine hydrochloride spray or honey-lemon spray for 5 weeks and continued for 1 week after the end of treatment. The oral cavity was examined weekly, with a score given to each site based on the degree of mucositis using a 4-point scale, and a mean mucositis score was calculated as the primary outcome. Occurrence of OM, pain, QoL, and adverse effects were defined as secondary outcomes. Patients, therapists, and outcome assessors were blinded to group allocation. Results: No significant group differences occurred in the mucositis score, pain, or QoL. Mucositis occurrence rates were higher in the benzydamine hydrochloride group compared with the honey-lemon group (hazard ratio = 2.1, 95% confidence interval: 1.1 to 4.2). Two patients in the honey-lemon group had mild nausea and burning throat; no adverse effects occurred in the benzydamine hydrochloride group. Conclusions: There were no significant group differences in mucositis severity between patients treated with honey-lemon spray and benzydamine hydrochloride. The potential preventive effects of honey-lemon spray need to be confirmed in further trials. The trial registration number is IRCT20161024030467N1.

Topical Costus sp. Preparation as Palliative Care for Chemotherapy-Induced Peripheral Neuropathy of Patients: A Randomized Placebo-Controlled Pilot Trial.

Objectives: Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of various anticancer regimens with different sensory-motor abnormalities in patients. The aim of this study was to examine the feasibility of using Costus sp. oil as a palliative treatment in such patients. Design: This was a pilot randomized placebo-controlled double-blind clinical study. Settings/Location: Imam Hossein Hospital, Tehran, Iran. Subjects: Patients 18-80 years of age undergoing chemotherapy treatment recently or during the last 6 months were enrolled after meeting the inclusion criteria. Interventions: The intervention group used Costus sp. as a topical ointment and the placebo group used topical paraffin for 4 weeks. Outcome measures: Feasibility of recruitment, including treatment acceptability (evaluated as number of patients leaving the study early), and compliance (defined as consumption of a minimum 80% of the ointment) with the intervention were assessed. Neuropathic pain change was defined as the secondary outcome, too. Results: Totally, 50 out of 73 participants were identified eligible and were randomly divided into intervention or placebo groups. There was no significant difference between groups in terms of sociodemographic data. At the end of the study, 24% (confidence interval [95% CI]: 9-45) (intervention group) and 12% (95% CI: 2-31) (placebo group) of patients revealed treatment unacceptability. Meanwhile, 12% (95% CI: 2-31) in the intervention group and 28% (95% CI: 12-49) in the placebo group did not show the compliance. Moreover, according to patients' records, pain reduction was higher in the intervention group compared to the placebo group (p = 0.001). Conclusions: This preliminary study showed that topical use of Costus sp. was feasible and acceptable in patients suffering from CIPN.