NCT06734598 Efficacy of Botox Injection of the Masticatory Muscles in Head &Neck Cancer Patients with Trismus After Radiotherapy
| NCT ID | NCT06734598 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | National Taiwan University Hospital |
| Condition | Trismus |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2024-12-01 with a primary completion date of 2025-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Trismus is a common side effect in head and neck cancer patients after radiation therapy. This project aims to explore the therapeutic effect of Botulinum toxin (Botox) injection to the masticatory muscles in the above-mentioned patients. In this project, Botulinum toxin will be injected into the masticatory muscles (medial pterygoid and masticatory muscles), combined with oral rehabilitation exercises, to reduce the patient's masticatory muscle tension and spasm. Patient's mouth opening range, quality of life, trismus condition and pain will be evaluated to understand its efficacy.
Eligibility Criteria
Inclusion Criteria: 1. Aged over 18 years old; 2. Head and neck cancer patients must have completed radiotherapy for at least 3 months; 3. Those whose mouth-opening distance is less than or equal to 3.5 cm (the functional cut-off point of trismus) and who have tightness or pain in the masticatory muscles; 4. Medical condition is stable; Exclusion Criteria: 1. Those who have undergone surgery on their masticatory muscles; 2. Patients with obvious muscle atrophy or complete fibrosis of masticatory muscles ; 3. Those with tumor recurrence at the time of admission; 4. Those whose vital signs are unstable due to acute illness.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06734598 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Trismus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06734598 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06734598 currently recruiting?
Yes, NCT06734598 is actively recruiting participants. Contact the research team at b00401020@ntu.edu.tw for enrollment information.
Where is the NCT06734598 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT06734598 clinical trial?
NCT06734598 is sponsored by National Taiwan University Hospital. The trial plans to enroll 120 participants.