Can a simple injection save your hearing during cancer treatment?
NCT ID NCT07218913
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests whether adding Pedmark to standard cisplatin chemotherapy can prevent hearing loss in men with metastatic testicular cancer. About 80% of patients currently develop hearing damage from cisplatin. Pedmark works by neutralizing harmful molecules that cause ear damage. The study will compare hearing outcomes between men who get Pedmark plus chemo and those who get chemo alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pedmark (sodium thiosulfate)
- What this could lead to
- If it works, this could point toward a way to prevent hearing loss in adults receiving cisplatin chemotherapy for testicular cancer.
- What could go wrong
- This is a very early Phase 1 trial with only 44 participants, so results may not be conclusive. Pedmark is already approved for children, but its effectiveness in adults is still uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 44 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Feb 2026
- Expected to finish
-
Jan 2031
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Male participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines * Willing and able to sign informed consent form * Willing and able to participate in baseline and serial audiometry exams * Age: ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) of 0 or 1 or Karnofsky score ≥ 70 * Histologically confirmed germ cell tumor (seminoma or non-seminoma) * Presence of metastatic disease (stage II or III) * Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy * Receiving first or second line cisplatin-based chemotherapy * Planned cumulative cisplatin dose of ≥ 300mg/m\^2 (including previous treatment) * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * Absolute neutrophil count (ANC) ≥ 1,500/mm\^3 * Platelets ≥ 100,000/mm\^3 * NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement * Hemoglobin ≥ 9g/dL * NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment unless cytopenia is secondary to disease involvement * Total bilirubin ≤ 1.5 X upper limit of normal (ULN) * Patients with known Gilbert disease who have serum bilirubin level \< 3 x ULN may be enrolled * Aspartate aminotransferase (AST) ≤ 3.0 x ULN * Alanine aminotransferase (ALT) ≤ 3.0 x ULN * Creatinine clearance of ≥ 60 mL/min per the Cockcroft-Gault formula or serum creatinine ≤ 1.5 x ULN * \* If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin (PT) ≤ 1.5 x ULN * If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants * \* If not receiving anticoagulants: Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN * If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants * Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 11 months after the last dose of cisplatin for injection Exclusion Criteria: * Any cisplatin-based therapies within 4 weeks prior to initiation of study treatment * If cisplatin infusion during study is planned to be longer than 6 hours, as Pedmark safety and efficacy has not been established when administered following longer cisplatin infusions * Chronic steroid use, defined as greater than prednisone 5 mg daily for longer than 21 days (steroids used as antiemetic during treatment is permitted) * Concurrent use of other ototoxic drugs other than cisplatin (loop diuretics, aminoglycosides, etc) * Patient must adhere to low sodium diet given other comorbidities * History of severe hypersensitivity to sodium thiosulfate or any components such as sulfites or thiols * Known symptomatic brain metastases, leptomeningeal carcinomatosis, or prior cranial irradiation * Deemed cisplatin ineligible due to poor performance status, cardiac dysfunction, renal insufficiency, or significant peripheral neuropathy * Greater than or equal to moderate hearing loss (HL) at baseline per World Health Organization (WHO) classification * Unstable cardiac disease as defined by one of the following: * Cardiac events such as myocardial infarction (MI) within the past 6 months * NYHA (New York Heart Association) heart failure class III-IV * Uncontrolled atrial fibrillation or hypertension * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Hearing loss are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
City of Hope Medical Center
RECRUITINGDuarte, California, 91010, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a smartphone app replace the clinic for hearing aid tuning?
- 30 years of cochlear implant data could reshape hearing care in china
- Can a new hearing aid strategy cut through the noise?
- Can a new bone conduction implant restore hearing for the long haul?
- Can eye movements reveal the hidden toll of hearing loss?
- A digital helping hand for new hearing aid wearers?