Phase 1 Hearing Loss Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have given written consent to participate (or whose legal representative has done so on their behalf)
• People who are willing and able to attend hearing tests at the start of the trial and at regular intervals throughout
• Adults aged 18 years or older
• People whose general health and ability to carry out daily activities meets a certain minimum level, as measured by standard medical scoring tools (confirm with trial site)
• People who have been diagnosed with a germ cell tumor (either seminoma or non-seminoma type), confirmed by laboratory tissue testing
• People whose cancer has spread to other parts of the body (stage II or III)
• People who have largely recovered from side effects of any previous cancer treatments (with hair loss being an acceptable exception)
• People who are currently receiving their first or second round of chemotherapy that includes the drug cisplatin
• People whose total planned cisplatin dose across all treatments is at least 300mg per square metre of body surface area
• People whose cancer can be measured using standard imaging criteria
• People whose blood counts, liver function, and kidney function fall within acceptable ranges as measured by standard blood tests (confirm with trial site)
• People whose blood clotting results fall within acceptable ranges, whether or not they are taking blood-thinning medication (confirm with trial site)
• Male patients with female partners who could become pregnant must be willing to use effective contraception during treatment and for 11 months after the last cisplatin dose

Who may not be able to join:

• People who have received cisplatin-based treatment within the 4 weeks before starting the trial
• People whose cisplatin infusion during the trial is planned to last longer than 6 hours
• People who regularly take steroid medications at a dose higher than the equivalent of 5mg of prednisone daily for more than 21 days (steroids used to manage nausea during treatment are permitted)
• People who are currently taking other medications known to cause hearing damage, such as certain antibiotics or water tablets, in addition to cisplatin
• People who must follow a low-sodium diet due to other health conditions
• People who have had a severe allergic reaction to sodium thiosulfate or related compounds such as sulfites or thiols
• People with active or symptomatic cancer that has spread to the brain or the lining around the brain, or who have previously had radiation treatment to the head
• People who have been assessed as unsuitable for cisplatin treatment due to poor general health, heart problems, kidney problems, or significant nerve damage
• People who already have moderate or greater hearing loss at the start of the trial, as classified by World Health Organization standards
• People with unstable heart conditions, including a heart attack within the past 6 months, severe heart failure, or uncontrolled irregular heartbeat or high blood pressure
• People who, in the opinion of the trial investigators, may not be able to follow all trial procedures

Important: Always verify eligibility with the trial site directly before applying.