Botulinum Toxin for Dry Mouth in Head and Neck Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

Disqualifiers: Previous radiation, Xerostomia, Salivary surgery, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

50 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug OnabotulinumtoxinA (Botox) for treating dry mouth in head and neck cancer patients?

Research shows that botulinum toxin (BoNT) is effective in reducing salivary flow, which can help manage salivary problems in head and neck cancer patients. Although a specific study found no significant difference in salivary gland function between BoNT and placebo, BoNT has been used successfully for other radiation-related issues, suggesting potential benefits that need further investigation. ^{1 2 3 4 5}

Is botulinum toxin safe for treating dry mouth in head and neck cancer patients?

Botulinum toxin, including OnabotulinumtoxinA (Botox), is generally considered safe for various treatments, but there can be side effects like mild to moderate swallowing difficulties (dysphagia) even at low doses. It has been used safely in many treatments, but patients should be aware of potential side effects. ^{6 7 8 9 10}

How does the drug OnabotulinumtoxinA differ from other treatments for dry mouth in head and neck cancer?

OnabotulinumtoxinA (Botox) is unique because it reduces salivary flow by temporarily blocking nerve signals to the salivary glands, which is different from other treatments that may not target the nerve pathways directly. This approach can help manage dry mouth symptoms in head and neck cancer patients, where standard treatments may not be available. ^{1 2 6 11 12}

What is the purpose of 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 is for patients with head and neck cancers who are about to undergo radiation therapy. The goal is to prevent severe dry mouth, a common side effect of the treatment. Participants should be adults at risk of xerostomia due to factors like age, advanced stage disease, or tumor location.

Inclusion Criteria

I have late-stage head and neck cancer and need radiotherapy.

Exclusion Criteria

I have had radiation treatment to my head or neck.

I have been treated for head and neck cancer before.

I have a history of dry mouth.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pretreatment

Injection of botulinum neurotoxin or placebo into salivary glands before radiation

1 week

1 visit (in-person)

Radiation

Participants undergo radiation therapy for head and neck cancer

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• OnabotulinumtoxinA

Trial Overview The study tests if injecting OnabotulinumtoxinA (a botulinum neurotoxin) into salivary glands before radiation can preserve gland function and reduce dry mouth in comparison to a placebo.

Participant Groups

Group I: onabotulinumtoxinA Experimental Treatment 1 Intervention

The treating physician will perform the injection of onabotulinumtoxinA under ultrasound guidance using a 30-gauge needle introduced into the salivary gland tissue. 30 units of onabotulinumtoxinA will be infiltrated the major salivary glands at-risk.

Group II: Placebo Placebo Group 1 Intervention

The treating physician will perform the injection of normal saline under ultrasound guidance using a 30-gauge needle introduced into the salivary gland tissue. 30 units of normal saline will be infiltrated the major salivary glands at-risk.

OnabotulinumtoxinA is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Botox for:

• Chronic migraine
• Involuntary muscle contractions or twitching
• Excessive sweating
• Increased saliva
• Overactive bladder
• Urinary incontinence
• Facial wrinkles
• Cervical dystonia
• Upper limb spasticity
• Lower limb spasticity

Approved in European Union as Botox for:

• Blepharospasm
• Strabismus
• Axillary hyperhidrosis
• Cervical dystonia
• Upper limb spasticity
• Lower limb spasticity
• Overactive bladder
• Urinary incontinence
• Facial wrinkles

Approved in Canada as Botox for:

• Chronic migraine
• Involuntary muscle contractions or twitching
• Excessive sweating
• Increased saliva
• Overactive bladder
• Urinary incontinence
• Facial wrinkles
• Cervical dystonia
• Upper limb spasticity
• Lower limb spasticity

Who Is Running the Clinical Trial?

Sir Mortimer B. Davis - Jewish General Hospital

Lead Sponsor

Trials

61

Recruited

25,800+

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

Collaborator

Trials

476

Recruited

170,000+

Lady Davis Institute

Collaborator

Trials

50

Recruited

6,600+

References

1. Greece pubmed.ncbi.nlm.nih.gov

Botulinum toxin for salivary disorders in the treatment of head and neck cancer. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

The role of botulinum toxin in the management of head and neck cancer patients. [2010]

3. England pubmed.ncbi.nlm.nih.gov

Botulinum toxin for radiation-induced facial pain and trismus. [2010]

4. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Botulinum Toxin to Preserve Gland Function after Radiotherapy in Patients with Head and Neck Cancer: A Prospective, Randomized, Placebo-Controlled, Double-Blinded Phase I Clinical Trial. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Botulinum Toxin Confers Radioprotection in Murine Salivary Glands. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Severity and impact of xerostomia in patients treated with botulinum toxin type b for cervical dystonia: Observations on the quality of life of patients with xerostomia. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Effect of recurrent onabotulinum toxin A injection into the salivary glands: An ultrasound measurement. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of botulinum toxin therapy in otorhinolaryngology: experience from 1,000 treatments. [2010]

9. United States pubmed.ncbi.nlm.nih.gov

Mild to Moderate Dysphagia Following Very Low-dose Abobotulinumtoxin A for Platysmal Bands. [2018]

10. Brazil pubmed.ncbi.nlm.nih.gov

Prevalence of hyposalivation and associated factors in survivors of head and neck cancer treated with radiotherapy. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Pilocarpine for the treatment of refractory dry mouth (xerostomia) associated with botulinum toxin type B. [2016]

12. United States pubmed.ncbi.nlm.nih.gov

Botulinum Toxin for Side-Effect Management and Prevention of Surgical Complications in Patients Treated for Head and Neck Cancers and Esophageal Cancer. [2020]