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Clinical Trial — Recruiting Now
🔬 Active Clinical Trial: NCT07622407 | Status: NOT_YET_RECRUITING | Phase: NA
A Clinical Trial Aims to Close a Critical Gap in Cancer Survivor Care
Head and neck cancer affects Veterans at three times the rate of the general population. The standard treatment, which often includes cisplatin chemotherapy and radiation, is effective but carries a known cost: 70% of patients develop significant hearing loss, and the same percentage experience trouble swallowing. While swallowing therapy is proactively provided, hearing and balance damage—known as ototoxicity—frequently goes undetected or is only addressed when severe. A new VA clinical trial, TIMELY REHAB, directly challenges this imbalance.
Key Takeaways
- The TIMELY REHAB trial will test a comprehensive rehabilitation program for Veterans receiving head and neck cancer treatment.
- It directly integrates proactive hearing and balance screening with the existing swallowing therapy, a combination not typically offered.
- The study aims to show that this coordinated approach can reduce stress and improve overall quality of life after cancer.
- The trial plans to enroll 74 participants and is currently in the pre-recruitment stage.
The Scientific Foundation: An Imbalance in Rehabilitation
Both dysphagia (swallowing difficulty) and ototoxicity are powerful, independent predictors of elevated stress and reduced quality of life in cancer survivors. Within the VA system, the Intensive Dysphagia Treatment (IDT) program successfully integrates speech pathology with oncology care, using telehealth to improve outcomes for swallowing. However, audiology services—which are managed alongside speech pathology in the VA—and other rehabilitation supports remain disconnected from this model. As a result, auditory and vestibular deficits, which rank as the third most prevalent service-connected disabilities for Veterans, are under-addressed during a critical window.
What the TIMELY REHAB Trial Involves
The study is an interventional trial at two VA sites. It will compare the current standard of care—swallowing therapy alone—against a new, multi-part program. The experimental intervention has three core components:
- The Standard IDT: This is the established swallowing therapy.
- Proactive Auditory-Vestibular Management: This is the trial’s central innovation. It involves quick screening tests and validated questionnaires administered during cancer treatment visits for convenience. Remote audiologists review these results via telehealth. They use personalized tools to predict and identify hearing issues early, then work with the patient and care team to arrange protection strategies or management if damage occurs.
- Coordinated Rehabilitation Services: A tele-oncology nurse uses a validated tool to screen for other rehabilitation needs, shares findings with the care team, and advises patients on recommended next steps.
Who Can Participate
The trial seeks 74 participants. Eligible individuals must have been diagnosed with a head and neck malignancy within the past 60 days and be prescribed a treatment plan at a participating site that includes either cisplatin-based chemotherapy or radiotherapy/surgery. Crucially, participants must also be prescribed the VA’s Intensive Dysphagia Therapy. Sufficient fluency in written English to complete questionnaires is required.
Potential participants will be excluded if they have distant metastasis at enrollment, a diagnosis of a second primary cancer in the thorax or central nervous system, a prior or planned total laryngectomy, a prior or planned cochlear implant, or previous head and neck radiotherapy for thyroid cancer.
Current Status and Future Implications
The trial is marked as NOT_YET_RECRUITING. The research team is preparing to enroll the first of the 74 planned participants. If successful, the results could directly influence standard oncology rehabilitation practice, particularly within the VA system.
The implications extend beyond a single condition. This model of integrated, proactive, and telehealth-enabled rehabilitation could serve as a template for other cancer populations where treatment side effects impact multiple sensory and functional systems. For patients, the potential is a significant shift from managing severe, late-stage hearing loss to preventing it or intervening early, thereby preserving communication, balance, and overall well-being during and after a challenging cancer journey.
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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