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Clinical Trial — Recruiting Now
🔬 Active Clinical Trial: NCT07622407 | Status: NOT_YET_RECRUITING | Phase: NA
A New Focus on Hearing and Balance in Cancer Recovery
Head and neck cancer treatment saves lives but can leave a lasting mark on hearing and balance. A planned clinical trial called TIMELY REHAB addresses this by testing a more complete rehabilitation model for Veterans. The trial compares the current standard of care—proactive therapy for swallowing problems—against a package that adds structured, proactive monitoring and management for hearing and balance.
Approximately 70% of patients treated with cisplatin chemotherapy and radiation for head and neck cancer develop hearing loss. Radiation alone causes swallowing difficulties at the same high rate. While swallowing rehabilitation is routinely integrated into cancer care for this group, similar attention to ototoxic side effects is often delayed or absent.
“Damage to the hearing and balance systems—known as ototoxicity—is often missed or addressed after becoming severe,” the trial investigators note. This gap directly impacts stress levels and overall quality of life for survivors.
Key Takeaways
- The TIMELY REHAB trial will test a comprehensive rehabilitation program for Veterans recovering from head and neck cancer.
- It adds proactive hearing and balance monitoring to the existing standard of swallowing therapy.
- The intervention uses telehealth and early screening to identify ototoxicity sooner.
- The goal is to reduce survivor stress and improve long-term quality of life.
- The trial is not yet recruiting and will enroll 74 participants across two VA sites.
How the TIMELY REHAB Trial Works
This is an interventional study with two arms. One group will receive the current standard of care: the VA’s established Intensive Dysphagia Treatment (IDT) program for swallowing. The other group will receive the experimental “TIMELY REHAB” package.
This new package has three components:
- Standard Swallowing Therapy: The same IDT program provided to the control group.
- Proactive Hearing and Balance Management: This core element involves quick screening tests and validated questionnaires administered during cancer treatment visits for patient convenience. An audiologist reviews these results remotely via telehealth. The team will also use new, personalized tools to predict and identify hearing problems early. The audiologist then coordinates any needed follow-up care with the patient and their oncology team.
- Coordinated Rehabilitation Services: A tele-oncology nurse uses a screening tool validated in Veterans to check for other rehabilitation needs, advises the care team, and guides patients toward recommended services.
The primary measure of success will be a reduction in patient-reported stress and an improvement in overall well-being compared to swallowing therapy alone.
The Science Behind the Care Gap
Head and neck cancer is diagnosed in Veterans at three times the rate of the general population. Cisplatin, a common chemotherapy drug, is highly ototoxic. It can damage the delicate hair cells in the inner ear, leading to permanent, often progressive, hearing loss and balance issues.
Despite auditory and vestibular deficits being the third most prevalent service-connected disability among Veterans, access to timely supportive audiology care during cancer treatment remains limited. Rehabilitation services like physical therapy or nutrition counseling are also underutilized. This fragmentation means Veterans often navigate these complex side effects separately, increasing their burden and hindering recovery.
Who Can Participate in This Trial?
The trial aims to enroll 74 participants across two VA sites. To be eligible, participants must have been diagnosed with a head and neck malignancy within the past 60 days and be prescribed a treatment plan that includes at least one dose of cisplatin-based chemotherapy, or radiotherapy and/or surgery. They must also be prescribed the IDT program for swallowing therapy.
Potential participants are excluded if they have distant metastasis at enrollment, a second primary cancer in the thorax or central nervous system, a prior or planned total laryngectomy, or a prior or planned cochlear implant.
The Potential Impact on Patient Care
If successful, the TIMELY REHAB model could change how rehabilitation is integrated into oncology care, particularly within the VA system. It provides a blueprint for bundling essential supportive services—speech, audiology, nursing, and broader rehabilitation—around the patient during their most critical treatment phase.
For patients, this approach means potential side effects like tinnitus, hearing loss, and dizziness could be identified and managed earlier, preventing them from reaching a severe, debilitating stage. Better coordination is expected to reduce the stress of navigating multiple appointments and specialists, directly improving the survivor experience.
The trial’s use of telehealth and remote monitoring also offers a template for delivering specialized care efficiently, which could benefit patients in rural or underserved areas. By focusing on the whole patient, not just the tumor, this research emphasizes that quality survival is as important as survival itself.
Source:
Maximizing Quality of Life After Cancer Through Rehabilitation (ClinicalTrials.gov: NCT07622407)
This article is for informational purposes only. Consult a qualified professional for personalised advice.
Medical Disclaimer
This article is for informational purposes only and does not constitute medical advice. The research summaries presented here are based on published studies and should not be used as a substitute for professional medical consultation. Always consult a qualified healthcare provider before making any changes to your health regimen.
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