Botulinum Toxin for Stomach Cancer Treatment

Study Overview
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Brief Summary
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Preclinical studies at our institution, using a genetic mouse model of gastric cancer, strongly suggest that innervation of the stomach wall is required not only for the development, but also for the progression of gastric cancer, and that denervation of the stomach either by vagotomy or by injection of botulinum toxin (Botox®) in the stomach wall may represent an effective therapeutic intervention. New treatment options for inoperable cancer in the stomach are urgently needed, and local treatment with botulinum toxin seems to be an attractive possibility. In this pilot study Botox injections will be given by gastroscopy in both the tumor and the surrounding stomach wall. The purpose of the study is to obtain data needed to calculate sample size in a larger controlled trial.

Official Title
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Botulinum Toxin (BOTOX) for Stomach Cancer Treatment

Conditions
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Stomach Neoplasms

Intervention / Treatment
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* Drug: Botox


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients with verified gastric adenocarcinoma but found non-resectable or inoperable after evaluation in the appropriate multidisciplinary team at St.Olav Hospital. Trondheim University Hospital. The inclusion criteria for such patients are: Patients who have received 1.line and 2. line chemotherapy but no longer respond to such therapy. Patients who, due to toxicity of chemotherapy, cannot be offered such treatment. Patients who, after meticulous information about chemotherapy, still do not want such treatment. Patients with performance status (ECOG) 0-2. Exclusion criteria: Known allergy to any of the components in Botox® Known peripheral motor neuropathy disease ( for example: Amyotrophic Lateral Sclerosis, ALS), or subclinical or clinical deficiency of neuromuscular transmission (for example: Myasthenia Gravis or Eaton-Lambert's Syndrome). Pregnant or lactating women. Another cancer disease that is not under control. Another concomitant treatment for cancer. Serious mental illness. Performance status (ECOG) 3-4.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botox<br>Injection of Botox in the tumor and surrounding stomach wall. | Drug: Botox<br>* injection by gastroscopy (100 Allergen units)<br>* Other names: Botulinum toxin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of tumor volume in the stomach. | Change measured with a standardized CT protocol (Thickness of the stomach wall and diameter of the tumor). | Baseline and 8 weeks | 
| Change of tumor volume in the stomach. | Change measured with a standardized CT protocol (Thickness of the stomach wall and diameter of the tumor). | 8 weeks and 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity | Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 | 2 weeks | 
| Toxicity | Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 | 8 weeks | 
| performance status | ECOG scale | 2 weeks | 
| performance status | ECOG scale | 8 weeks | 
| performance status | ECOG scale | 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Botulinum Toxins, Injections, Stomach, Tomography, X-Ray Computed