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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to prevent dry mouth (xerostomia) in patients with head and neck cancer undergoing radiation therapy. Researchers are testing whether injecting botulinum toxin (a medicine often used to relax muscles) into the salivary glands can help maintain their function during treatment. The trial includes two groups: one receiving the botulinum toxin (OnabotulinumtoxinA) and the other receiving a placebo (a harmless substance for comparison). It seeks patients with newly diagnosed advanced head and neck cancer who require radiation therapy and have not undergone previous treatments like radiation or major salivary gland surgery. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potential advancements in cancer care.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that onabotulinumtoxinA, the treatment being tested, is generally safe. A review found it effective and mostly free from serious side effects. Common side effects include dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems. A study examining various uses of onabotulinumtoxinA also confirmed its safety, with no new side effects reported. While some side effects are known, they are usually not severe, and the treatment is generally well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for dry mouth?

Researchers are excited about onabotulinumtoxinA for treating dry mouth in head and neck cancer patients because it offers a novel approach compared to existing treatments like saliva substitutes and medications that stimulate saliva production. Unlike these standard options, onabotulinumtoxinA is injected directly into the salivary glands using ultrasound guidance, which allows for targeted treatment. This method aims to modify gland function by using a well-known neurotoxin to potentially reduce excessive dryness, providing relief in a more direct and potentially effective manner. Moreover, this treatment might offer longer-lasting effects with fewer systemic side effects compared to oral medications.

What evidence suggests that onabotulinumtoxinA might be an effective treatment for dry mouth in head and neck cancer?

This trial will compare the effects of OnabotulinumtoxinA (Botox) with a placebo for treating dry mouth in head and neck cancer patients. Research has shown that Botox, a well-known treatment, can help reduce saliva production, benefiting patients who experience dry mouth due to radiation therapy. Studies have found that Botox can ease dry mouth and reduce swelling in the salivary glands caused by radiation. It blocks nerve signals that instruct the salivary glands to produce saliva, which may help maintain gland function during radiation treatment. Early research also suggests that Botox might help relieve pain after cancer radiation therapy. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

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.

Hypersensitivity to onabotulinumtoxinA

I have had major surgery on my salivary glands.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7874868/

The whole truth about botulinum toxin – a review - PMC Treatment with botulinum toxin is widely viewed as safe, effective and largely devoid of serious side effects. There are two classes of Botox-related ...

2. withpower.com withpower.com/trial/botulinum-toxin-for-dry-mouth-in-head-and-neck-cancer-8bc41

Botulinum Toxin for Dry Mouth in Head and Neck Cancer Research shows that botulinum toxin (BoNT) is effective in reducing salivary flow, which can help manage salivary problems in head and neck cancer patients.

3. mdpi.com mdpi.com/2077-0383/14/6/2021

Botulinum Toxin Therapy: A Comprehensive Review on ... Clinical trials, including the PREEMPT studies, demonstrated its effectiveness in significantly reducing headache days, pain intensity, and reliance on acute ...

4. link.springer.com link.springer.com/article/10.1007/s00253-021-11741-w

Botulinum toxin in cancer therapy—current perspectives ... Botulinum toxin (BoNTs) may be useful in cancer treatment. Botulinum toxin can serve as an analgesic after cancer radiotherapy.

5. researchgate.net researchgate.net/publication/372131925_Botox_for_the_prevention_of_radiation-induced_Sialadenitis_and_xerostomia_in_head_and_neck_cancer_patients_A_pilot_study

Botox for the prevention of radiation-induced Sialadenitis ... Radiation therapy (RT) induced sialadenitis in head and neck cancer patients can be relieved by Botox, according to Nieri et al. (2023) . The researchers ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4839970/

Botulinum Toxin Confers Radioprotection in Murine ... Xerostomia is a common radiation sequela, which has a negative impact on the quality of life of patients with head and neck cancer.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666328723001451

Safety and tolerability of onabotulinumtoxinA in the ... This meta-analysis confirms the onabotulinumtoxinA safety profile for GL, CFL, and FHL treatment, with no new onabotulinumtoxinA-associated AEs.

8. allerganaesthetics.com allerganaesthetics.com/brands/botox

BOTOX® Cosmetic (onabotulinumtoxinA) Other side effects of BOTOX® Cosmetic include dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; and eye problems ...