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Atorvastatin to Reduce Cisplatin-Induced Hearing Loss Among Individuals With Head and Neck Cancer

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 758 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. 2 versions Re-verified since Jun 4, 2026, no change to tracked fieldsv757-v758
  2. Eligibility criteria shortened, about 1 wordv756 See this version in full on ClinicalTrials.gov ↗
  3. Re-verified, no change to tracked fieldsv755
  4. Site details revised at 3 of 5 sitesv754
  5. Re-verified, no change to tracked fieldsv753
Show 44 earlier versionsHide 44 earlier versions
  1. Study sites: 4 to 5v752
  2. Re-verified, no change to tracked fieldsv751
  3. Eligibility criteria expanded, about 35 words Study description shortened, about 1 wordv750 Show 1 more changeShow less
    • Study description shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. 2 versions Re-verified since Feb 6, 2025, no change to tracked fieldsv748-v749
  5. Enrollment target: 214 to 224v747
  6. Study Status, Study Description, Eligibilityv746
  7. Re-verified, no change to tracked fieldsv745
  8. Start date changed from estimate of Aug 12, 2024 to Jul 10, 2024v744
  9. Start date: Aug 11, 2024 to Aug 12, 2024v743
  10. Start date: Aug 8, 2024 to Aug 11, 2024v742
  11. Start date: Aug 7, 2024 to Aug 8, 2024v741
  12. Start date: Aug 6, 2024 to Aug 7, 2024v740
  13. Start date: Aug 5, 2024 to Aug 6, 2024v739
  14. Start date: Aug 4, 2024 to Aug 5, 2024v738
  15. Start date: Aug 1, 2024 to Aug 4, 2024v737
  16. Start date: Jul 31, 2024 to Aug 1, 2024v736
  17. Start date: Jul 30, 2024 to Jul 31, 2024v735
  18. Start date: Jul 29, 2024 to Jul 30, 2024v734
  19. Start date: Jul 28, 2024 to Jul 29, 2024v733
  20. Start date: Jul 25, 2024 to Jul 28, 2024v732
  21. Start date: Jul 24, 2024 to Jul 25, 2024v731
  22. Start date: Jul 23, 2024 to Jul 24, 2024v730
  23. Start date: Jul 22, 2024 to Jul 23, 2024v729
  24. Start date: Jul 21, 2024 to Jul 22, 2024v728
  25. Start date: Jul 18, 2024 to Jul 21, 2024v727
  26. Start date: Jul 17, 2024 to Jul 18, 2024v726
  27. Start date: Jul 15, 2024 to Jul 17, 2024v725
  28. Start date: Jul 14, 2024 to Jul 15, 2024v724
  29. Start date: Jul 11, 2024 to Jul 14, 2024v723
  30. Start date: Jul 9, 2024 to Jul 11, 2024v722
  31. Start date: Jul 8, 2024 to Jul 9, 2024v721
  32. Start date: Jul 7, 2024 to Jul 8, 2024v720
  33. Start date: Jul 4, 2024 to Jul 7, 2024v719
  34. Start date: Jul 3, 2024 to Jul 4, 2024v718
  35. Start date: Jul 2, 2024 to Jul 3, 2024v717
  36. Start date: Jul 1, 2024 to Jul 2, 2024v716
  37. Start date: Jun 30, 2024 to Jul 1, 2024v715
  38. Start date: Jun 27, 2024 to Jun 30, 2024v714
  39. Start date: Jun 26, 2024 to Jun 27, 2024v713
  40. Start date: Jun 23, 2024 to Jun 26, 2024v712
  41. Start date: Jun 20, 2024 to Jun 23, 2024v711
  42. Start date: Jun 19, 2024 to Jun 20, 2024v710
  43. Start date: Jun 18, 2024 to Jun 19, 2024v709
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: Cisplatin is used to treat head and neck cancer. People who take this drug are at risk for hearing loss. Atorvastatin is a drug used to treat high cholesterol. It might reduce the risk of cisplatin-induced hearing loss. Objective: To find out if atorvastatin reduces hearing loss in people treated with cisplatin and radiation. Eligibility: People ages 18 and older with squamous cell carcinoma of the head and neck who will undergo treatment with cisplatin-based chemotherapy and radiation Design: Participants will be screened with their medical records. Participants currently taking a cholesterol-lowering statin medication are invited to participate in the observational arm of the study. Those not taking such a medication are invited to participate in the interventional arm of the study. All participants will have 3 study visits for the purpose of evaluating hearing. One before starting cisplatin treatment, one within 3 months of completing cancer treatment, and one within 2 years of completing cancer treatment. They will have tympanograms. A small flexible tip will be placed in the ear canal. A puff of air will be delivered to assess mobility of the ear drum. They will have hearing tests. They will wear headphones. They will listen to tones that vary in loudness. They will be asked to indicate when they hear a sound. They will complete 3 questionnaires at the time of each hearing test. Participants will have 2 visits for blood tests. These will occur upon consent and 12 weeks after. They will be randomly assigned to take the study drug or placebo orally, once daily. They will take it during cisplatin treatment and for 3 months after treatment. Long-term follow up will include a chart review 2 years after participants complete their cisplatin therapy.
Trial Details
NCT Number NCT04915183
Lead Sponsor National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions Hearing Loss, Head and Neck Cancer
Enrollment 224 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov