Dataset Information

A novel formulation for radiotherapy-induced oral mucositis: Triamcinolone acetonide mucoadhesive film.

ABSTRACT: Background:The main purpose of this study was to evaluate the effectiveness of triamcinolone acetonide (TA) mucoadhesive films versus placebo as a preventive and therapeutic intervention of oral mucositis (OM) induced by radiotherapy for head-and-neck cancer (HNC) patients. Materials and Methods:In this double-blind, randomized case-controlled clinical trial, 60 HNC patients were randomized to receive TA mucoadhesive films (n = 30) or placebo mucoadhesive films (n = 30) taken four times daily. Mucositis severity was assessed during the course of radiation therapy using the World Health Organization scales, and pain scores were assessed using visual analog scale. Repeated measures ANOVA was used for data analysis. Results:Mean ± standard deviation age of the TA group was 58.53 ± 8.89 years and 60% were male, whereas in the placebo group, it was 56.46 ± 9.36 years and 56.7% were male (P > 0.05). The mean value of pain score was significantly reduced in the TA group (5.36 ± 1.29 vs. 2.20 ± 2.02) compared with the placebo group (5.34 ± 0.78 vs. 4.69 ± 0.77) during 4 weeks (P < 0.001); repeated measures ANOVA analysis showed that the mean value of grade mucositis was significantly reduced in the TA group (2.40 ± 0.49 vs. 0.96 ± 0.81) compared with the placebo group (2.36 ± 0.80 vs. 1.86 ± 0.93) during 4 weeks (P < 0.001). Conclusion:TA film could be considered as an effective approach for reducing the mucositis grading and pain score in the patients with OM.

SUBMITTER: Pakravan F

PROVIDER: S-EPMC6669991 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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A novel formulation for radiotherapy-induced oral mucositis: Triamcinolone acetonide mucoadhesive film.

Pakravan Fahimeh F Ghalayani Parichehr P Emami Hamid H Isfahani Mehdi Nasr MN Noorshargh Pegah P

Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences 20190724

<h4>Background</h4>The main purpose of this study was to evaluate the effectiveness of triamcinolone acetonide (TA) mucoadhesive films versus placebo as a preventive and therapeutic intervention of oral mucositis (OM) induced by radiotherapy for head-and-neck cancer (HNC) patients.<h4>Materials and methods</h4>In this double-blind, randomized case-controlled clinical trial, 60 HNC patients were randomized to receive TA mucoadhesive films (<i>n</i> = 30) or placebo mucoadhesive films (<i>n</i> = ...[more]

PMID: 31523249

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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:The leukotriene receptor antagonist Montelukast (MTK) is an approved medication for the treatment of asthma and allergic rhinitis. The existing marketed tablet forms of MTK exhibit inconsistent uptake and bioavailability, which partially explains the presence of a significant proportion of MTK low- and non-responders in the population. Besides that, tablets are suboptimal formulations for patients suffering from dysphagia, for example, seen in patients with neurodegenerative diseases such as Alzheimer's disease, a disease with increasing interest in repurposing of MTK. This, and the need for an improved bioavailability, triggered us to reformulate MTK. Our aim was to develop a mucoadhesive MTK film with good safety and improved pharmacological features, i.e., an improved bioavailability profile in humans as well as in a mouse model of Alzheimer's disease. We tested dissolution of the MTK mucoadhesive film and assessed pharmacoexposure and kinetics after acute and chronic oral application in mice. Furthermore, we performed a Phase I analysis in humans, which included a comparison with the marketed tablet form as well as a quantitative analysis of the MTK levels in the cerebrospinal fluid. The novel MTK film demonstrated significantly improved bioavailability compared to the marketed tablet in the clinical Phase 1a study. Furthermore, there were measurable amounts of MTK present in the cerebrospinal fluid (CSF). In mice, MTK was detected in serum and CSF after acute and chronic exposure in a dose-dependent manner. The mucoadhesive film of MTK represents a promising alternative for the tablet delivery. The oral film might lower the non-responder rate in patients with asthma and might be an interesting product for repurposing of MTK in other diseases. As we demonstrate Blood-Brain-Barrier (BBB) penetrance in a preclinical model, as well as in a clinical study, the oral film of MTK might find its use as a therapeutic for acute and chronic neurodegenerative diseases such as dementias and stroke.

Project description:BackgroundIntra-articular corticosteroids are commonly used for pain relief in patients with knee osteoarthritis. Simultaneous intra-articular corticosteroid (CS) knee injections may be beneficial for the ~80-90% of patients who present with, or develop, bilateral knee osteoarthritis, but concurrent injections may increase systemic CS exposure and data on safety/tolerability are lacking. Triamcinolone acetonide extended release (TA-ER) has shown decreased systemic triamcinolone acetonide exposure compared with traditional triamcinolone acetonide crystalline suspension (TAcs) after a single knee injection in patients with knee osteoarthritis. This phase IIa study was designed to assess the safety and systemic triamcinolone acetonide exposure following injections of TA-ER or TAcs into each knee of patients with bilateral knee osteoarthritis.MethodsPatients (⩾40 years) meeting American College of Rheumatology criteria for knee osteoarthritis in both knees received concurrent single intra-articular injections of TA-ER 32 mg or TAcs 40 mg into each knee (total: 64 mg and 80 mg, respectively) and were followed for 6 weeks. Safety was evaluated based on treatment-emergent adverse events (TEAEs). Blood samples for pharmacokinetic analysis were collected pre-injection, and at the following postinjection time points: 1, 2, 3, 4, 5, 6, 8, 10, 12, and 24 h, and days 8, 15, 29, and 43.ResultsBaseline characteristics were balanced between patients randomly assigned to TA-ER (n = 12) or TAcs (n = 12). Both treatments were well tolerated with comparable TEAE profiles. Peak plasma triamcinolone acetonide concentrations (Cmax) were lower following bilateral TA-ER injections [geometric mean, 2277.7 pg/ml (95% CI, 1602.13-3238.04)] compared with bilateral TAcs injections [7394.7 pg/ml (2201.06-24,843.43)], with median times to Cmax (Tmax) of 4.5 and 6.5 h, respectively.ConclusionsIn patients with bilateral knee osteoarthritis, intra-articular injection of TA-ER into both knees was well tolerated. Consistent with pharmacokinetic profiles observed after a single knee injection, plasma triamcinolone acetonide concentrations were lower after bilateral TA-ER injections compared with the higher and more variable concentrations observed after bilateral TAcs injections.Clinicaltrialsgov identifierNCT03378076.

Dataset Information

A novel formulation for radiotherapy-induced oral mucositis: Triamcinolone acetonide mucoadhesive film.

Publications

A novel formulation for radiotherapy-induced oral mucositis: Triamcinolone acetonide mucoadhesive film.

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