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87 active trials for Hearing Loss

Phase III Interventional Study Using Atorvastatin to Reduce Cisplatin-Induced Hearing Loss Among Individuals With Head and Neck Cancer

Study Description: Individuals undergoing cisplatin-based chemoradiation therapy are at risk for developing significant, permanent hearing loss. The cholesterol-lowering drug atorvastatin has the potential to reduce the incidence and severity of hearing loss, as evidenced by our preclinical data in mice and our retrospective data in humans.Here we will compare hearing changes between subjects on a concurrent daily dose of atorvastatin vs. a placebo among individuals undergoing cisplatin therapy to treat head and neck cancer. Objectives: Primary Objective (Interventional Arm): To determine the effectiveness of atorvastatin (20 mg) at reducing the incidence of a CTCAEv5.0 Grade >=2 hearing loss in patients treated with cisplatin-based CRT for head and neck squamous cell carcinoma (HNSCC). Secondary Objective (Observational Arm): To examine the extent to which subjects taking other statin drugs (and other doses of atorvastatin) exhibit reduced incidence CTCAEv5.0 grade >=2 hearing loss in patients treated with cisplatin-based CRT for head and neck squamous cell carcinoma (HNSCC). Tertiary Objectives (Interventional Arm): To determine if concomitant atorvastatin (20 mg) use alters disease-free survival or overall survival in subjects undergoing cisplatin therapy. Endpoints: Primary Endpoint (Interventional Arm): The primary endpoint is the change in hearing sensitivity as measured by pure-tone audiometry between the pre-treatment (before cisplatin-based CRT) hearing test and the post-treatment (after completion of cisplatin-based CRT) audiogram. Hearing loss will be defined according to CTCAEv5.0 Grade >=2 criteria and will be compared in subjects taking atorvastatin vs. subjects not taking any statin drug. Hearing sensitivity will be compared between audiograms collected at baseline prior to treatment to a repeated audiogram at the end of treatment within 2-4 months of cessation of cisplatin administration. Secondary Endpoints (Observational Arm): The secondary endpoint is the change in hearing sensitivity as measured by pure-tone audiometry between the pre-treatment )(before cisplatin-based CRT) hearing test and the post-treatment (within 2-4 months of cessation of cisplatin administration) audiogram in the observational arm of the study. Hearing loss will be defined according to CTCAEv5.0 Grade >=2 criteria and will be compared in subjects taking: 1) any statin other than atorvastatin vs. subjects not taking any statin drug, 2) subjects taking atorvastatin at doses other than 20 mg vs. subjects not taking any statin. Hearing sensitivity will be compared between audiograms collected at baseline prior to treatment to a repeated audiogram at the end of treatment within 2-4 months of cessation of cisplatin administration. Tertiary Endpoint (Interventional Arm): The tertiary endpoint is the overall survival and disease-free survival at 2 years after cisplatin therapy. Overall survival and disease-free survival will be compared between subjects taking atorvastatin (20 mg) vs. those not taking any statin. Study Population: Up to 414 adult male and female patients newly diagnosed with head and neck squamous cell carcinoma scheduled to undergo cisplatin-based chemotherapy with concurrent radiation. Subjects will be recruited from 3-4 U.S.-based sites. Phase: Phase 3 Description of Sites/Facilities Enrolling Participants: Multi-institutional study including U.S.-based cancer centers providing standard-of-care therapy for in head and neck cancer: Wilmot Cancer Institute at the University of Rochester Medical Center in New York, the Winship Cancer Institute at Emory University in Georgia, and possibly the University of Maryland Medical Center in Maryland. Description of Study Intervention: Multi-institutional study including U.S.-based cancer centers providing standard-of-care therapy for in head and neck cancer: National Institutes of Health (NIH) Clinical Center, Wilmot Cancer Institute at the University of Rochester Medical Center in New York, the Winship Cancer Institute at Emory University in Georgia, and possibly the University of Maryland Medical Center in Maryland. Study Duration: 48 months of active study enrollment + 2 years to obtain follow-up survival data. Participant Duration: 7 months with up to 2 year follow up.

Bethesda, MarylandStart: September 2021