Efficacy of Botox Injection of the Masticatory Muscles in Head &Neck Cancer Patients with Trismus After Radiotherapy

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Aged over 18 years old;

Head and neck cancer patients must have completed radiotherapy for at least 3 months;

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;

Medical condition is stable;

Disqualifiers

Those who have undergone surgery on their masticatory muscles;

Patients with obvious muscle atrophy or complete fibrosis of masticatory muscles ;

Those with tumor recurrence at the time of admission;

Those whose vital signs are unstable due to acute illness.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Echo-guided Botox injection

    Drug

    Echo-guided Botox injection to the masticatory muscles

  • echo-guided normal saline injection

    Procedure/Surgery

    echo-guided normal saline injection

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Botox injectionExperimental treatment 1 intervention
Group B: Normal Saline InjectionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Maximal Incisal Opening

Time frame
From enrollment to the end of treatment at 6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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