KEY TAKEAWAYS
- The phase I/II SPOM trial aimed to evaluate the efficacy of benzydamine mouthwash and Bocaliner for OM prevention in chemo pts.
- The study will assess the variation in the incidence of OM using the WHO Oral Toxicity Scale as the primary endpoint.
- The safety and tolerability of a new medical device to prevent OM are being assessed in the Phase I study, and enrollment is ongoing until the end of 2023.
Oral mucositis (OM), often from cancer treatment, causes mouth pain and dysfunction. Preventive measures, like oral care, have varying success. Bocaliner is a novel medical device that prolongs topical therapies in the oral cavity. Researchers aimed to evaluate the efficacy of benzydamine mouthwash and Bocaliner for OM prevention in chemo patients (pts).
The study of 100 adult pts with hematologic malignancies (undergoing chemotherapy in a centralized hematology center in Armenia) will be randomized into two different treatment groups, namely saline mouthwash and benzydamine mouthwash (0.15%, 120mL) (3-5 times a day for a total of two weeks). Half of the pts within each group will also randomly receive Bocaliner, which will be placed inside their mouth immediately after the application of the mouthwash (for 20 minutes). Block randomization will be applied with 4 patients per block with 1:1 randomization based on gender, Bocaliner use, and mouthwash type.
The primary endpoint is the difference in OM incidence (measured by the WHO Oral Toxicity Scale). The secondary endpoints are differences in OM symptoms evaluated using a modified version of the PROMS questionnaire. The Phase I of the study will assess the medical device’s safety using standardized tryout responses (Day 0) and follow-up questionnaires (Day 14). They will also evaluate OM duration and severity. Statistical analysis will investigate meaningful links between patient data, treatments, and outcomes.
While 42 patients finished the study, enrollment continues, targeting completion by late 2023.
Source: https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.TPS12149
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT05338398
Artem Oganesyan, Lusine Harutyunyan, Araksya Vanoyan, Nare Martirosyan, Maria Badikyan, Nerses Ghahramanyan, Hasmik Oseyan, Levon Evoyan, Armine Farmazyan, Amalya Chakhoyan, Hayk Grigoryan, Anahit Ter-Grigoryan, Anna Sevoyan, Avetis Gharibyan, Anahit Aynajyan, Karapet Hakobyan, and Yervand Hakobyan. DOI: 10.1200/JCO.2023.41.16_suppl.TPS12149 Journal of Clinical Oncology 41, no. 16_suppl (June 01, 2023) TPS12149-TPS12149.
