Sodium Thiosulfate for Hearing Loss During Cancer Treatment

TW
MC
Overseen ByMichele Chu-Pilli
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: University of Arizona
Must be taking: Cisplatin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the drug Pedmark® sodium thiosulfate (STS) can protect against hearing loss during cisplatin cancer treatment. While STS has reduced hearing issues in children, this study focuses on its effects in adults. It seeks participants who are beginning their first cisplatin treatment for cancer and have not previously been exposed to cisplatin. Those currently taking medications that affect hearing or with a history of severe allergic reactions to similar substances may not qualify. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial requires that you stop taking any ototoxic medications (drugs that can harm your hearing) if they cannot be safely discontinued or switched to a safer alternative.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that sodium thiosulfate (STS) is generally safe and can help prevent hearing loss in children receiving cisplatin, a common cancer treatment. Studies have found that administering STS after cisplatin treatment reduces the risk of hearing damage. This treatment, already approved for children and young adults, protects the ears from harmful effects.

In terms of safety, younger patients tolerate the treatment well, with no major side effects reported in these studies. Since it is approved for children, it may also be safe for adults, although limited data exists for adults. This trial aims to gather more information about its safety in adult patients.12345

Why do researchers think this study treatment might be promising?

Sodium thiosulfate is unique because it has the potential to protect hearing without interfering with cancer treatment. Unlike standard treatments for hearing loss, which typically focus on rehabilitation after damage has occurred, sodium thiosulfate is administered intravenously immediately following cisplatin chemotherapy to prevent hearing damage from happening in the first place. Researchers are excited because it offers a proactive approach, aiming to shield the ears from the toxic effects of chemotherapy, which is a significant advancement over the reactive strategies currently available. This could mean preserving hearing for patients undergoing essential cancer treatments, significantly improving their quality of life.

What is the effectiveness track record for sodium thiosulfate in reducing hearing loss during cancer treatment?

Research shows that sodium thiosulfate (STS) can help prevent hearing loss caused by cisplatin, a common cancer treatment. Clinical studies have found that STS reduces the risk of hearing damage in patients taking cisplatin. Although approved for children and young adults, its effectiveness in adults remains under investigation. In this trial, participants will receive STS after their standard cisplatin treatment to evaluate its potential to protect hearing during cancer treatment. Previous research demonstrated that adding STS after cisplatin treatment led to less hearing loss, suggesting its protective benefits.46789

Who Is on the Research Team?

LD

Lisa Davis, PharmD

Principal Investigator

University of Arizona

AR

Alejandro Recio-Boiles, MD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

Adults at least 18 years old with various untreated solid cancers, including testicular and lung cancer, who are about to start standard cisplatin chemotherapy can join. They must be relatively healthy (ECOG 0-1) and have agreed to the study's procedures.

Inclusion Criteria

I am fully active or can carry out light work.
My cancer has not been treated before and was confirmed by a lab test.
I have given my consent to participate in the study.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Pedmark® STS via intravenous infusion after standard cisplatin therapy

Up to 12 months
Multiple visits as per treatment schedule

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months
Follow-up visit at 3 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

  • Sodium Thiosulfate

Trial Overview

The trial is testing Pedmark® sodium thiosulfate (STS), a drug aimed at protecting against hearing loss in adults receiving cisplatin chemotherapy for solid tumors. The effectiveness of STS has been shown in younger patients but needs evaluation in adults.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Study Treatment ArmExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials
545
Recruited
161,000+

Fennec Pharma

Collaborator

Trials
1

Citations

Use of Sodium Thiosulfate as an Otoprotectant in Patients ...

In summary, systemic STS has been shown to effectively reduce the occurrence of hearing loss in controlled clinical studies in both adults and ...

Sodium Thiosulfate for Protection from Cisplatin-Induced ...

The addition of sodium thiosulfate, administered 6 hours after cisplatin chemotherapy, resulted in a lower incidence of cisplatin-induced hearing loss.

Press Release - Fennec Pharmaceuticals Inc.

Study, Which Enrolled 27 Patients, Met Primary Endpoint with a Significant Reduction in Hearing Loss in 3-18 Year Old Patients who Received ...

A Phase 3 Study of Sodium Thiosulfate for Reduction of ...

Previous studies with STS have shown that it may help reduce or prevent hearing loss caused by cisplatin. In the low-risk medulloblastoma ...

Use of Sodium Thiosulfate as an Otoprotectant in Patients ...

Thirty-one articles were summarized. Overall, systemic STS effectively reduces CIHL in the preclinical and controlled clinical study settings, ...

Page 1 of 12 - accessdata.fda.gov

PEDMARK is a prescription medicine used to decrease the risk of hearing loss in children 1 month of age and older who are receiving cisplatin for solid tumors ( ...

Press Release - Fennec Pharmaceuticals Inc.

The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of those treated will require lifelong hearing aids.

Prevention of cisplatin-induced hearing loss in children - PMC

To prevent hearing loss, sodium thiosulfate (STS), which binds to cisplatin, and reduces the superoxides in both tumor and outer hair cells of the cochlea has ...

Sodium Thiosulfate Reduces Hearing Loss in Kids with ...

Sodium thiosulfate prevents hearing loss and is safe. Cisplatin belongs to a group of platinum-based chemotherapy drugs. Research has ...