Dataset Information

Prevention of radiotherapy-related oral mucositis with zinc and polyherbal mouthwash: a double-blind, randomized clinical trial.

ABSTRACT:

Background

A significant percentage of head and neck cancer (HNCs) patients receiving RT experience oral mucositis (OM). This study aimed to evaluate the effect of the polyherbal (containing chamomile, peppermint oil, Aloe vera, and honey) and zinc mouthwashes in comparison to the control (chlorhexidine) and placebo groups for prevention of radiation-induced OM.

Methods

This study was a double-blinded randomized clinical trial, conducted on 67 patients with HNCs undergoing radiotherapy. The eligible participants were randomized to receive either one of the following; zinc sulfate, polyherbal, chlorhexidine (Vi-one 0.2% CHX), or placebo mouthwash for 6 weeks. Follow-up evaluation of oral hygiene and the checklists of OM and the intensity of pain were filled out according to WHO assessment tool, Oral Mucositis Assessment Scale (OMAS), and Visual Analog Scale (VAS) in all the participants weekly for seven consecutive weeks.

Results

The results of present clinical trial demonstrated that the use of either zinc sulfate or polyherbal mouthwash significantly reduced the scores of OM and the severity of pain during weeks 2 to 7 after consumption compared with the CHX or placebo mouthwashes (P < 0.05). According to the post hoc analysis and compared with the placebo, a significantly better result was reported for zinc sulfate and polyherbal mouthwashes at weeks 2 to 7, but not for the CHX mouthwash.

Conclusion

This study showed that the use of zinc sulfate or polyherbal mouthwashes is effective in prevention of both OM severity scores and pain related to OM intensity at weeks 2 to 7 following consumption in HNCs patients. Trial registration IRCT20190123042475N1 and IRCT20190123042475N2. Registration date: 2019-06-09, 2019-07-26.

SUBMITTER: Sahebnasagh M

PROVIDER: S-EPMC9979417 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

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Publications

Prevention of radiotherapy-related oral mucositis with zinc and polyherbal mouthwash: a double-blind, randomized clinical trial.

Sahebnasagh Marzieh M Aksi Vahideh V Eslami Fatemeh F Lashkardoost Hossein H Kasaian Jamal J Golmohammadzadeh Shiva S Parkam Bahareh B Negarandeh Reza R Saghafi Fatemeh F Sahebnasagh Adeleh A

European journal of medical research 20230302 1

<h4>Background</h4>A significant percentage of head and neck cancer (HNCs) patients receiving RT experience oral mucositis (OM). This study aimed to evaluate the effect of the polyherbal (containing chamomile, peppermint oil, Aloe vera, and honey) and zinc mouthwashes in comparison to the control (chlorhexidine) and placebo groups for prevention of radiation-induced OM.<h4>Methods</h4>This study was a double-blinded randomized clinical trial, conducted on 67 patients with HNCs undergoing radioth ...[more]

PMID: 36864527

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Project description:One of the most common side effects of radiotherapy in head and neck cancers is mucositis. Despite all the studies conducted on new therapies proposed for oral mucositis caused by radiation therapy, a single standard treatment strategy has not been developed yet. In the present study, for the first time, the effectiveness of the treatment with a combined mouthwash containing vitamin E (as an antioxidant), triamcinolone (as an anti-inflammatory agent) and hyaluronic acid (HA) (as a local reducer used for reducing the effects of ROS on the mucosa, with ameliorative effects (improving the healing process) compared to triamcinolone mouthwash alone was investigated in patients with radiotherapy-induced oral mucositis. This study was a randomized triple-blind clinical trial performed on 60 patients underwent radiotherapy on an outpatient basis. The combined mouthwash containing vitamin E, triamcinolone, and hyaluronic acid compared to triamcinolone mouthwash alone was prescribed for 4 weeks. The severity of oral mucositis was assessed based on the WHO classification and the intensity of pain was assessed using the numerical pain intensity scale. According to the analysis performed in the first, second, third and fourth weeks, the reduction of oral mucositis grade in the intervention group was significantly higher than in the comparison group. In the first, second, third, and fourth weeks, the reduction in pain intensity in the intervention group was significantly higher than in the comparison group (P < 0.001). The combined mouthwash containing vitamin E, hyaluronic acid and triamcinolone acetonide can be used as an effective treatment for oral mucositis caused by radiation therapy, which is probably the result of antioxidant, anti-inflammatory and improved healing process mechanisms due to the biological nature of the components of this mouthwash.Trial registrationThis study was registered in the WHO Primary registry (IRCT) with the code IRCT20190428043407N. Registered on 20 July 2019, https://www.irct.ir/trial/39231.

Project description:ImportanceOral mucositis causes substantial morbidity during head and neck radiotherapy. In a randomized study, doxepin mouthwash was shown to reduce oral mucositis-related pain. A common mouthwash comprising diphenhydramine-lidocaine-antacid is also widely used.ObjectiveTo evaluate the effect of doxepin mouthwash or diphenhydramine-lidocaine-antacid mouthwash for the treatment of oral mucositis-related pain.Design, setting, and participantsA phase 3 randomized trial was conducted from November 1, 2014, to May 16, 2016, at 30 US institutions and included 275 patients who underwent definitive head and neck radiotherapy, had an oral mucositis pain score of 4 points or greater (scale, 0-10), and were followed up for a maximum of 28 days.InterventionsNinety-two patients were randomized to doxepin mouthwash (25 mg/5 mL water); 91 patients to diphenhydramine-lidocaine-antacid; and 92 patients to placebo.Main outcome and measuresThe primary end point was total oral mucositis pain reduction (defined by the area under the curve and adjusted for baseline pain score) during the 4 hours after a single dose of doxepin mouthwash or diphenhydramine-lidocaine-antacid mouthwash compared with a single dose of placebo. The minimal clinically important difference was a 3.5-point change. The secondary end points included drowsiness, unpleasant taste, and stinging or burning. All scales ranged from 0 (best) to 10 (worst).ResultsAmong the 275 patients randomized (median age, 61 years; 58 [21%] women), 227 (83%) completed treatment per protocol. Mucositis pain during the first 4 hours decreased by 11.6 points in the doxepin mouthwash group, by 11.7 points in the diphenhydramine-lidocaine-antacid mouthwash group, and by 8.7 points in the placebo group. The between-group difference was 2.9 points (95% CI, 0.2-6.0; P = .02) for doxepin mouthwash vs placebo and 3.0 points (95% CI, 0.1-5.9; P = .004) for diphenhydramine-lidocaine-antacid mouthwash vs placebo. More drowsiness was reported with doxepin mouthwash vs placebo (by 1.5 points [95% CI, 0-4.0]; P = .03), unpleasant taste (by 1.5 points [95% CI, 0-3.0]; P = .002), and stinging or burning (by 4.0 points [95% CI, 2.5-5.0]; P < .001). Maximum grade 3 adverse events for the doxepin mouthwash occurred in 3 patients (4%); diphenhydramine-lidocaine-antacid mouthwash, 3 (4%); and placebo, 2 (2%). Fatigue was reported by 5 patients (6%) in the doxepin mouthwash group and no patients in the diphenhydramine-lidocaine-antacid mouthwash group.Conclusions and relevanceAmong patients undergoing head and neck radiotherapy, the use of doxepin mouthwash or diphenhydramine-lidocaine-antacid mouthwash vs placebo significantly reduced oral mucositis pain during the first 4 hours after administration; however, the effect size was less than the minimal clinically important difference. Further research is needed to assess longer-term efficacy and safety for both mouthwashes.Trial registrationClinicalTrials.gov Identifier: NCT02229539.

Project description:Chemotherapy-induced oral mucositis is an extremely serious complication faced by cancer patients. The role of oral zinc sulfate in preventing and treating chemotherapy-induced oral mucositis remains a subject of debate. The aim of this systematic review is to assess the potential of oral zinc sulfate to alleviate this morbid condition. A systematic search was conducted electronically in PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) to capture all potential randomized controlled trials investigating efficacy and safety of oral zinc sulfate in prevention and treatment of chemotherapy-induced oral mucositis, and the retrieval time was limited from their inception to April 2018. We assigned two independent investigators to perform a search, screen citations, extract information, and evaluate the risk of bias in all included trials. Subsequently, the RevMan 5.3 software was utilized to perform all statistical analyses. We included five eligible studies involving 352 patients. Meta-analysis based on limited data revealed that oral zinc sulfate failed to decrease the incidence of chemotherapy-induced oral mucositis (RR [relative risk] = 0.52, 95% CI [confidence interval] = 0.17-1.64) as well as relieve chemotherapy-induced oral mucositits grade (RR = 0.62, 95% CI = 0.11-3.56; RR = 0.70, 95% CI = 0.29-1.71). Moreover, qualitative analyses also suggested that oral zinc sulfate was not associated with reduced oral pain intensity, delayed onset of chemotherapy-induced oral mucositis, decreased adverse events, or improved quality of life compared with control regimes. Oral zinc sulfate may not provide clinical benefits in preventing or reducing incidence, severity, or pain intensity of chemotherapy-induced oral mucositis in cancer patients. However, more studies with large-scale and rigorous methods are warranted for the purpose of further investigating efficacy and safety of oral zinc sulfate for this pathologic condition due to the presence of limitations.

Project description:Purpose: Oral mucositis (OM) remains a common, debilitating toxicity of radiation therapy (RT) for head and neck cancer. The goal of this phase IIb, multi-institutional, randomized, double-blind trial was to compare the efficacy and safety of GC4419, a superoxide dismutase mimetic, with placebo to reduce the duration, incidence, and severity of severe OM (SOM).Patients and methods: A total of 223 patients (from 44 institutions) with locally advanced oral cavity or oropharynx cancer planned to be treated with definitive or postoperative intensity-modulated RT (IMRT; 60 to 72 Gy [≥ 50 Gy to two or more oral sites]) plus cisplatin (weekly or every 3 weeks) were randomly assigned to receive 30 mg (n = 73) or 90 mg (n = 76) of GC4419 or to receive placebo (n = 74) by 60-minute intravenous administration before each IMRT fraction. WHO grade of OM was assessed biweekly during IMRT and then weekly for up to 8 weeks after IMRT. The primary endpoint was duration of SOM tested for each active dose level versus placebo (intent-to-treat population, two-sided α of .05). The National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03, was used for adverse event grading.Results: Baseline patient and tumor characteristics as well as treatment delivery were balanced. With 90 mg GC4419 versus placebo, SOM duration was significantly reduced (P = .024; median, 1.5 v 19 days). SOM incidence (43% v 65%; P = .009) and severity (grade 4 incidence, 16% v 30%; P = .045) also were improved. Intermediate improvements were seen with the 30-mg dose. Safety was comparable across arms, with no significant GC4419-specific toxicity nor increase of known toxicities of IMRT plus cisplatin. The 2-year follow-up for tumor outcomes is ongoing.Conclusion: GC4419 at a dose of 90 mg produced a significant, clinically meaningful reduction of SOM duration, incidence, and severity with acceptable safety. A phase III trial (ROMAN; ClinicalTrials.gov identifier: NCT03689712) has begun.

Dataset Information

Prevention of radiotherapy-related oral mucositis with zinc and polyherbal mouthwash: a double-blind, randomized clinical trial.

Background

Methods

Results

Conclusion

Publications

Prevention of radiotherapy-related oral mucositis with zinc and polyherbal mouthwash: a double-blind, randomized clinical trial.

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