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Titre : | Oral D-methionine protects against cisplatin-induced hearing loss in humans: phase 2 randomized clinical trial in India (2022) |
Auteurs : | Kathleen C. Campbell ; Alnawez Rehemtulla ; Prasad Sunkara ; Daniel Hamstra ; Michael Buhnerkempe ; Brian Ross |
Type de document : | Article |
Dans : | International Journal of Audiology IJA (vol. 61, no. 8, août 2022) |
Article en page(s) : | p. 621-631 |
Note générale : | https://doi.org/10.1080/14992027.2021.1983215 |
Langues: | Anglais |
Descripteurs : |
HE Vinci Cisplatine ; Ototoxicité ; Seuil auditif ; Troubles de l'audition |
Mots-clés: | Méthionine |
Résumé : |
Objective: This exploratory Phase 2 clinical trial is the first determining safety and efficacy of oral D-methionine (D-met) in reducing cisplatin-induced ototoxicity.
Design: Randomised parallel double-blind placebo-controlled exploratory Phase 2 study. Study samples: Fifty adult cancer patients received oral D-met or placebo before each cisplatin dose. Physical examination, blood collection and audiometry occurred at baseline and subsequent visits plus post-treatment audiometry. After attrition, final analysis included 27 patients. Results: Significant treatment group by ear and time (baseline vs. post-treatment) interactions occurred at 10 kHz and 11.2 kHz. Placebo and D-met groups differed in threshold shift for left ear at 11.2 kHz (mean difference = 22.97 dB [9.59, 36.35]). Averaging across ears, placebo group showed significant threshold shifts from baseline to post-treatment at 10 kHz (mean shift= −13.65 dB [−21.32,−5.98]), 11.2 kHz (−16.15 dB [−25.19,−7.12]), and 12.5 kHz (−11.46 dB [−19.18,−3.74]) but not 8 kHz (−8.65 dB [−17.86, 0.55]). The D-met group showed no significant threshold shifts (8 kHz: −1.25 dB [−7.75, 5.25]; 10 kHz:−3.93 dB [−8.89, 1.03]; 11.2 kHz:−4.82 dB [−11.21, 1.57]; 12.5 kHz:−3.68 dB [−11.57, 4.21]). Side effects did not significantly differ between groups. Conclusion: Oral D-met reduces cisplatin-induced ototoxicity in humans. |
Accès : | Contactez la bibliothèque d'Ixelles si le lien vers la ressource électronique ne fonctionne pas |
Disponible en ligne : | Oui |
En ligne : | https://login.ezproxy.vinci.be/login?url=https://www.tandfonline.com/doi/full/10.1080/14992027.2021.1983215 |