Skip to content

Prevention of Cisplatin-induced ototoxicity

Clinical trial Comparison of Sertraline and Placebo to reduce Cisplatin-induced ototoxicity in patients with Cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016081927286N1
Enrollment
70
Registered
2016-10-29
Start date
2016-10-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Hearing loss. Condition 2: Hearing loss. Condition 3: Hearing loss. Condition 4: Hearing loss. Other and unspecified types of non-Hodgkin lymphoma Hodgkin lymphoma Non-follicular lymphoma Malignant neoplasm of stomach

Interventions

Intervention 1: Case groups: Sertraline, 50 mg oral tablet, starting dose with 25 mg once daily and if tolerated 50 mg per day continues for 3 months. Intervention 2: Control group: placebo, Saccharin
Prevention
Case groups: Sertraline, 50 mg oral tablet, starting dose with 25 mg once daily and if tolerated 50 mg per day continues for 3 months
Control group: placebo, Saccharin oral tablet, a daily pill for three months

Sponsors

Investigator
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: patients with cancer who are scheduled to receive Cisplatin; aged 20 to 65 years. Exclusion criteria: previous use of Cisplatin or any ototoxic drug; patients with Head and Neck cancer; age above 65 years; patients who use hearing aids or those associated with hearing loss in the past otalgic disease; Steroid user; patients with systemic diseases such as Diabetes, Hypertension, Thyroid disease, Kidney or Liver disease; pregnant or lactating women; patients with a history of Seizure; taking Monoamine Oxidase inhibitors; concomitant use of Antidepressants drugs; history of radiotherapy.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Hearing frequencie. Timepoint: Before the intervention, After the intervention. Method of measurement: Distorsion product Otoacoustic Emission, High frequency tympanoaudiometery.

Secondary

MeasureTime frame
The side effects of taking Sertraline. Timepoint: Before the intervention, After the intervention. Method of measurement: Interview.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Karbasi

Medical System

Karbasi.z@iums.ac.ir+98 213169787

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026