Clinical trial · Interventional

Dexamethasone in Preventing Hearing Loss in Patients Receiving Cisplatin

Prevention of Cisplatin-Induced Ototoxicity by Intratympanic Dexamethasone

NCT02382068CI-TRIAL-00030271withdrawnN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): No patients were enrolled to trial

Summary

Brief summary (as posted)

This randomized pilot clinical trial studies dexamethasone in preventing hearing loss in patients receiving cisplatin. Injecting a steroid, such as dexamethasone, behind the eardrum before chemotherapy may help protect against cisplatin-associated hearing loss.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Malignant Neoplasm	Malignant Neoplasm	ONTOLOGY_EXACT	0.90
Ototoxicity	—	UNRESOLVED	—

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
Cisplatin	Drug	Cisplatin	ALIAS
Dexamethasone	Drug	Dexamethasone	ALIAS
Placebo	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Supportive care (intratympanic dexamethasone)
description
Patients receive dexamethasone via intratympanic injection in one ear and placebo via intratympanic injection in the other ear. Cisplatin standard of care treatment.
interventionNames
1. Drug: Dexamethasone
2. Other: Placebo
3. Drug: Cisplatin

Primary outcomes (1)

measure
Change in score of pure tone audiometry of conventional and high-frequency ranges (hearing level decibels [dB] hearing level)
timeFrame
Baseline to up to 3 months after completion of cisplatin treatment
description
Change score will be assessed comparing baseline testing (prior to first cisplatin treatment) and various monitoring intervals (prior to each successive cisplatin treatment and 1 month and 3 months following completion of cisplatin treatment). Analyzed using a repeated measures model and a multi-level model.

Secondary outcomes (2)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Planned cisplatin treatment restricted to the following treatment course criteria:

  * Dose: \> 50 mg/m\^2
  * Frequency: every (q)3-q4 weeks
  * Cycles: 7 maximum

Exclusion Criteria:

* Previous cisplatin treatment
* Previous or concurrent radiation treatment to the head and neck region
* Previous or existing pathology of the external or middle ear which would preclude auditory testing and/or intratympanic dexamethasone delivery
* Previous or existing pathology of the inner ear with or without hearing loss (i.e. sudden sensorineural hearing loss, Meniere's disease, autoimmune inner ear disease)
* Previous or existing pathology of the central nervous system with potential to impact auditory pathways (i.e. major head trauma, meningitis, encephalitis, brain metastasis, vestibular schwannoma)
* Recent steroid treatment within the last month

References

Publications (0)

Data not yet available

No reference posted for this study.