Oral D-methionine protects against cisplatin-induced hearing loss in humans : phase 2 randomized clinical trial in India
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:61 |
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| Enthalten in: |
International journal of audiology - 61(2022), 8 vom: 08. Aug., Seite 621-631 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Campbell, Kathleen C [VerfasserIn] |
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| Links: |
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| Themen: |
AE28F7PNPL |
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| Anmerkungen: |
Date Completed 02.08.2022 Date Revised 02.09.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1080/14992027.2021.1983215 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM331637278 |
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| 500 | |a Citation Status MEDLINE | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a D-methionine | |
| 650 | 4 | |a Phase 2 Clinical Trial | |
| 650 | 4 | |a cisplatin | |
| 650 | 4 | |a efficacy | |
| 650 | 4 | |a otoprotectant | |
| 650 | 4 | |a ototoxicity | |
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| 650 | 7 | |a AE28F7PNPL |2 NLM | |
| 650 | 7 | |a Cisplatin |2 NLM | |
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| 700 | 1 | |a Sunkara, Prasad |e verfasserin |4 aut | |
| 700 | 1 | |a Hamstra, Daniel |e verfasserin |4 aut | |
| 700 | 1 | |a Buhnerkempe, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Ross, Brian |e verfasserin |4 aut | |
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