SPI-1005 for Chemotherapy-Induced Hearing Loss
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called SPI-1005, an experimental drug, to determine its effectiveness in preventing and treating hearing loss and tinnitus caused by certain chemotherapy drugs. The study will assess the safety and efficacy of SPI-1005 by testing three different doses alongside a placebo, which contains no active drug. People with advanced head and neck or lung cancer undergoing chemotherapy may be suitable candidates, especially if concerned about hearing issues from their treatment. Participants will take SPI-1005 or a placebo twice daily for three days around each chemotherapy session. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you've been treated with certain chemotherapy, antibiotics, or diuretics that cause hearing loss in the last 90 days, you cannot participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that SPI-1005 is generally safe for humans. Different studies found no serious side effects directly linked to the treatment. Most reported side effects were mild to moderate. For example, studies involving patients with Meniere's disease and other conditions reported side effects similar in type and severity, regardless of the dose. This suggests that SPI-1005 might be a safe option for those considering participation in a clinical trial.12345
Why do researchers think this study treatment might be promising for preventing chemotherapy-induced hearing loss?
Unlike the standard treatments for chemotherapy-induced hearing loss, like corticosteroids or antioxidants, SPI-1005 offers a unique approach by using ebselen, a synthetic compound that mimics the action of an enzyme called glutathione peroxidase. This enzyme plays a crucial role in protecting cells from damage caused by oxidative stress, which is a key factor in hearing loss during chemotherapy. Researchers are excited about SPI-1005 because it not only targets this oxidative stress more directly but also has a convenient oral capsule form, making it easier for patients to take. Plus, the study is exploring different dosages, which might help tailor the optimal treatment for different patients.
What evidence suggests that SPI-1005 could be effective for preventing chemotherapy-induced hearing loss and tinnitus?
Research has shown that SPI-1005 can reduce hearing loss caused by certain treatments. Studies have found it protects hearing in patients taking cisplatin, a common chemotherapy drug that often leads to hearing problems. SPI-1005 has also shown promise in treating hearing loss from other causes, such as loud noise. Other trials have found it safe and effective for conditions like Meniere's disease, which also affects hearing. This trial will evaluate different dosages of SPI-1005—high, middle, and low—to determine its effectiveness in reducing chemotherapy-induced hearing loss. These findings suggest that SPI-1005 could benefit those at risk of hearing loss from chemotherapy.36789
Who Is on the Research Team?
Jonathan Kil, MD
Principal Investigator
Sound Pharmaceuticals, Inc.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive SPI-1005 or placebo orally twice daily for 3 days surrounding each cycle of platinum chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- SPI-1005
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sound Pharmaceuticals, Incorporated
Lead Sponsor
VA Puget Sound Health Care System
Collaborator