Ear, Nose, and Throat Diseases

Nervous System Diseases

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Ototoxicity

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All Drugs and Chemicals

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Gastrointestinal Agents

Tin Fluorides

Cisplatin

Azasetron

Serotonin

Neurotransmitter Agents

Subjects receiving cisplatin-based chemotherapy without receiving SENS-401. This control arm will provide natural history data, particularly the incidence and the time to onset of hearing impairment due to ototoxicity.

Subjects receiving 43.5 mg of oral SENS-401 b.i.d for up to 23 weeks. This arm will provide data on the potential protective effects of SENS-401 on cisplatin induced ototoxicity.

Patients will receive SENS-401 ((R)-azasetron besylate) B.I.D. up to 23 weeks: 1 week prior to the initiation of the cisplatin treatment, during the whole duration of the chemotherapy treatment (estimated to last up to 18 weeks) and 4 weeks after stopping chemotherapy.

SENS-401 (R-Azasetron Besylate)

Marion Laborie, MSc

Géraldine Honnet, MD

Christophe Tournigand, M.D.

This study is intended to evaluate the ability of SENS-401 to prevent the ototoxicity induced by cisplatin in subjects with a neoplastic disease. It is a multicenter, randomized, controlled, two-arm, open-label efficacy and safety study in adults with neoplastic disease requiring treatment with cisplatin as part of the chemotherapy protocol plan.

This study is intended to evaluate the ability of SENS-401 to prevent the ototoxicity induced by cisplatin in subjects with a neoplastic disease. It is a multicenter, randomized, controlled, two-arm, open-label efficacy and safety study in adults with neoplastic disease requiring treatment with cisplatin as part of the chemotherapy protocol plan. Cisplatin treatment per chemotherapy protocol must be given at a cumulative dose high enough to significantly increase the iatrogenic likelihood of ototoxicity (unit cisplatin dose of at least 70 mg/m2 and cumulative cisplatin dose of at least 210 mg/m²). If all the eligibility criteria are met, subjects will be randomized to one of two study arms as follows:

* Study Arm A (control arm): Subjects receiving cisplatin-based chemotherapy without receiving SENS-401. This control arm will provide natural history data, particularly the incidence and the time to onset of hearing impairment due to ototoxicity.
* Study Arm B: Subjects receiving 43.5 mg of oral SENS-401 b.i.d for up to 23 weeks: 1 week prior to the initiation of the cisplatin treatment, during the whole duration of the chemotherapy treatment (estimated to last up to 18 weeks) and 4 weeks after stopping chemotherapy. This arm will provide data on the potential protective effects of SENS-401 on cisplatin induced ototoxicity.

All subjects will be followed up to 12 weeks after the completion of the cisplatin therapy.

SENS-401 to Prevent the Ototoxicity Induced by Cisplatin in Adult Subjects With a Neoplastic Disease

A Phase IIa, Multicenter, Randomized, Controlled, Open Label Study to Evaluate the Efficacy of SENS-401 to Prevent the Ototoxicity Induced by Cisplatin in Adult Subjects With a Neoplastic Disease

Change from baseline of the average of the hearing threshold of 3 contiguous hearing frequencies assessed with a 0.5-12.5 kHz audiogram 4 weeks after the completion of the last cisplatin treatment in each ear of each subject.

Change from baseline of the average of the hearing threshold of 3 contiguous hearing frequencies assessed with a 0.5-12.5 kHz audiogram 12 weeks after the completion of the last cisplatin treatment in each ear of each subject.

Change from baseline in the distribution of hearing loss severity at 4 weeks after the completion of cisplatin treatment. The severity of the hearing loss being based on the CTCAE (version 5.0).

Change from baseline in the distribution of hearing loss severity at 12 weeks after the completion of cisplatin treatment. The severity of the hearing loss being based on the CTCAE (version 5.0).

Change from baseline in speech discrimination test score (assessed in noise and in quiet) 4 weeks after the completion of the cisplatin treatment.

Change from baseline in speech discrimination test score (assessed in noise and in quiet) 12 weeks after the completion of the cisplatin treatment.

Change from baseline in Tinnitus Handicap Inventory (THI) Questionnaire score, 4 weeks after the completion of the cisplatin treatment.

Change from baseline in Tinnitus Handicap Inventory (THI) Questionnaire score,12 weeks after the completion of the cisplatin treatment.

Sensorion

Neoplasms

Head and Neck Neoplasms

Anti-Infective Agents

Respiratory System Agents

Acetylcysteine

N-monoacetylcystine

Antiviral Agents

Expectorants

Antioxidants

Protective Agents

Antidotes

Oral administration of drug, before, during and after Chemoradiotherapy including Cisplatin.

N Acetylcysteine

Placebo Oral Tablet

Introduction. Cisplatin-induced ototoxicity is a very frequent event and its consequences can cause a lot of deterioration in patients. Early diagnosis is essential because it would allow the appropriate implementation of strategies to reduce its effect. Among these N-acetylcysteine, an antioxidant agent that has shown otoprotective effect. Study design. Randomized, parallel design and placebo controlled clinical trial. Methods. Patients with head and neck cancer who require treatment with cisplatin were enrolled in 2 branches: a control group that receives a placebo and experimental group that receives the drug. High-frequency audiometries (6 - 16 KHz) are performed before, during and after the treatment finalization.

Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer

Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer. A Randomized, Placebo Controlled Clinical Trial

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
SENS-401 to Prevent the Ototoxicity Induced by Cisplatin in Adult Subjects With a Neoplastic Disease	NCT05628233	Hearing Loss Ot...	SENS-401 (R-Aza...	18 Years -	Sensorion
Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer	NCT03400709	Cisplatin Adver... Hearing Loss Ot...	N Acetylcystein... Placebo Oral Ta...	18 Years -	Hospital San Juan de Dios, Santiago
SENS-401 to Prevent the Ototoxicity Induced by Cisplatin in Adult Subjects With a Neoplastic Disease	NCT05628233	Hearing Loss Ot...	SENS-401 (R-Aza...	18 Years -	Sensorion

Spots Global Cancer Trial Database for hearing loss ototoxic