E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10033109 |
E.1.2 | Term | Ototoxicity |
E.1.2 | System Organ Class | 10013993 - Ear and labyrinth disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this trial is to evaluate the protecting effect of Lysomucil® 10% against Cisplatin-induced ototoxicity. In this case, we will evaluate its effect through the transtympanic administration in both ears. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives include: - Evaluate the effect of the treatment on patients’quality of life. - Evaluate the impact of the treatment on the risk of discontinuation of the Cisplatin chemotherapy when an ototoxicity occurs.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- ≥ 18-year-old - Patients suffering from a neoplasic disease for which treatment protocol includes Cisplatin.
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E.4 | Principal exclusion criteria |
- Women of childbearing potential pregnant or with intention to become pregnant within the trial duration NOTE: Women of childbearing potential should use adequate birth control measures, as defined by the investigator. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Such methods include: - Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) - Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) - Intrauterine device (IUD) - Intrauterine hormone-releasing system (IUS) - Bilateral tubal occlusion - Vasectomized partner - Sexual abstinence (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient) - Women who are breastfeeding - Pathological findings on otoscopy that do not allow safe intratympanic drug delivery and reliable distortion product otoacoustic emissions (DPOAEs) testing. - Conductive hearing loss > 20dBHL - Meniere disease - Medical history of sudden hearing loss - Sensoryneural Hearing loss (SNHL) with mean ≥ 40dbHL Pure Tonal Audiometry (PTA)
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint is the apparition of ototoxicity as defined by the International Common Terminology Criteria for Adverse Events (CTCAE), version 5:
- A Threshold shift of 15 - 25 dB averaged at 2 contiguous test frequencies in at least one ear
- and/or the apparition of a tinnitus (not previously present).
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
- A Threshold shift of 15 - 25 dB averaged at 2 contiguous test frequencies in at least one ear = 6 months after the last administration of treatment.
- and/or the apparition of a tinnitus (not previously present) = 6 months after the last administration of treatment. |
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E.5.2 | Secondary end point(s) |
- Evaluate the apparition of ototoxicity defined by the inclusion of high frequency audiometry (Tune Grading System)
- Quality of life (Evaluation of the Impact of Hearing Loss in Adults (ERSA), Tinnitus Handicap Index (THI)) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Evaluate the apparition of ototoxicity defined by the inclusion of high frequency audiometry (Tune Grading System) = 6 months after the last administration of treatment.
- Quality of life (Evaluation of the Impact of Hearing Loss in Adults (ERSA), Tinnitus Handicap Index (THI)) = 6 months after the last administration of treatment. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of study occurs when all of the following criteria have been satisfied: 1. Thirty days after all patients have stopped protocol treatment 2. The trial is mature for the analysis of the primary endpoints as defined in the protocol 3. The database has been fully cleaned and frozen for this analysis.
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |