| Titre : | Evaluating the Efficacy of Intratympanic Dexamethasone in Protecting Against Irreversible Hearing Loss in Patients on Cisplatin-Based Cancer Treatment: A Randomized Controlled Phase IIIB Clinical Trial (2022) |
| Auteurs : | Inmaculada Moreno ; Antonio Belinchon |
| Type de document : | Article |
| Dans : | Ear and hearing (Vol.43, n°2, Mars-avril 2022) |
| Article en page(s) : | p. 676-684 |
| Langues: | Anglais |
| Descripteurs : |
HE Vinci Cisplatine ; Déficience auditive ; Dexaméthasone ; Membrane du tympan ; Ototoxicité |
| Résumé : |
Objective: To determine the efficacy of long-term high-dose intratympanic dexamethasone in protecting the hearing capacity of cancer patients undergoing cisplatin-based ototoxic treatment.
Design: A randomized controlled phase IIIB clinical trial to evaluate the efficacy of dexamethasone in protecting against hearing loss in patients undergoing cisplatin treatment. The subjects participating in the clinical trial were patients with a neoplastic disease whose treatment protocol included cisplatin. The average dose of cisplatin was 444.87 mg (SD 235.2 mg). Treatment consisted of intratympanically administering dexamethasone via a passive diffusion device called Microwick (8 mg/24 h dose) from the start of treatment with cisplatin to 3 weeks after the last cycle. Patients were administered the medication to one ear, and the contralateral ear was used as the control. The treated ears were randomly chosen using a computer system (randomization). The hearing threshold was evaluated using pure tone audiometry before each cisplatin cycle. Results: Thirty-four patients were recruited over a 2-year period at a reference tertiary hospital, of whom 11 were excluded. Forty-six ears were analyzed (23 treated and 23 control ears). When treatment was completed, the audiometric analysis showed a higher hearing threshold in the study group than in the control group. Differences were statistically significant at frequencies of 500, 1000, and 6000 Hz: 4.9 dB (1.1 to 8.7), 5.5 dB (0.8 to 10.3), and 16 dB (3.2 to 28.7), respectively, (p Conclusions: Long-term high-dose intratympanic dexamethasone treatment did not prevent cisplatin-induced hearing loss. |
| Disponible en ligne : | Oui |
| En ligne : | https://login.ezproxy.vinci.be/login?url=https://journals.lww.com/ear-hearing/fulltext/2022/03000/evaluating_the_efficacy_of_intratympanic.38.aspx |
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