IRCT20081202001483N4
Recruiting
Phase 3
Comparison of cisplatin otoprotection using intratympanic diltiazem and placebo among patients with solid cancer
Rasht University of Medical Sciences0 sites25 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Hearing Loss.
- Sponsor
- Rasht University of Medical Sciences
- Enrollment
- 25
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age over 18 years old
- •Presence of Acoustic Reflex or Tympanometry A
- •In PTA, average hearing threshold at frequencies of 3000\-5000 or 8000 to 4000 less than 40 dB
- •In PTA, the hearing threshold on either side should not be asymetric within 3000 to 5000 or 8000\-4000 Hz frequencies or there is less than 10 dB
- •The karnofsky index is equal to or greater than 70
Exclusion Criteria
- •History of previous internal ear disease that may reduce the sensory nervous system hearing
- •History of Meniere's disease Or fluticating hearing loss
- •Observing pathologic findings in otoscopy
- •Previously cisplatin has not been treated
- •Radiation History to the head and neck Area
- •Candidate for radiation to the head and neck
- •Liver and Renal failure
- •Conductive hearing loss more than 5 dB
- •Heart problems, such as hypotension or AV block
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A trial to identify if Aspirin can reduce hearing loss for patients receiving Cisplatin chemotherapyEUCTR2012-001509-25-GBniversity Hospital Southampton NHS Foundation Trust94
Not yet recruiting
Not Applicable
Comparative response evaluation of Cisplatin-Capecitabine with Cisplatin-5-Fluorouracil in advanced gastric carcinoma.Clinically diagnosed and histopathologically proved advanced gastric carcinoma (AJCC Stage IV).Advanced gastric carcinoma.TCTR20170715001Bangabandhu Sheikh Mujib Medical University62
Completed
Not Applicable
Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck CancerCisplatin Adverse ReactionHearing Loss OtotoxicNCT03400709Hospital San Juan de Dios, Santiago45
Active, not recruiting
Phase 1
Randomized Phase II study of chemotherapy (cisplatin) plus radiotherapy (RT) versus immunotherapy durvalumab or immunotherapy, durvalumab and tremelimumab, given with and/or after RT in patients with advanced cancer of the oropharynx that contains the human papilloma virusEUCTR2019-000308-13-BEEuropean Organisation for Research and Treatment of Cancer (EORTC)180
Active, not recruiting
Phase 1
Randomized Phase II study of chemotherapy (cisplatin) plus radiotherapy (RT) versus immunotherapy durvalumab or immunotherapy, durvalumab and tremelimumab, given with and/or after RT in patients with advanced cancer of the oropharynx that contains the human papilloma virusOropharyngeal Squamous Cell CarcinomaMedDRA version: 20.1Level: LLTClassification code 10079785Term: Oropharyngeal squamous cell carcinoma stage IVSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2019-000308-13-ITEuropean Organisation for Research and Treatment of Cancer (EORTC)180