Pretreatment Botulinum Toxin in Head and Neck Cancer Surgery

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSir Mortimer B. Davis - Jewish General Hospital

About this trial

Head and neck cancer care, including tumors of the mouth, nose, throat and voice box, often requires radiation for cure to be achieved. Despite advances in radiation, 40% to 60% of patients experience a significant dry mouth (xerostomia) following radiotherapy. Several factors are associated with severe xerostomia including older age, advanced stage disease and tumor location. Currently, no pragmatic treatment strategy exists to reduce the risk of radiation-related xerostomia in patients with head and neck cancer. The investigators propose the use of a botulinum neurotoxin injected into the at-risk salivary glands before radiation as a strategy to preserve salivary gland function during radiation treatments and reduce xerostomia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Newly diagnosis AJCC 8th edition Stage III/IVa mucosal head and neck squamous cell carcinoma requiring definitive radiotherapy (with or without chemotherapy).

Disqualifiers

Previous radiation to the head and neck

Previous treatment for head and neck cancer

Personal history of xerostomia

Hypersensitivity to onabotulinumtoxinA

Trial design

Design model

Parallel

Treatments tested in this trial

  • OnabotulinumtoxinA

    Drug

    Injection of onabotulinumtoxinA into the at-risk major salivary glands

  • Placebo

    Drug

    Injection of normal saline into the at-risk major salivary glands

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: onabotulinumtoxinAExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Xerostomia-related quality of life

University of Washington Quality of Life questionnaire (higher score is better)

Time frame
Pretreatment, 6 and 12 months from treatment completion

Secondary outcomes

1

Unstimulated salivary function using salivary gland scintigraphy

Measurement of unstimulated salivary gland flow prior to initiation of therapy and at 12 months from completion of therapy

Time frame
Pretreatment and 12 months from treatment completion

Other outcomes

Sponsors and contacts

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Sir Mortimer B. Davis - Jewish General Hospital

Lead sponsor

Lady Davis Institute

Collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborator

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