Botulinum Toxin for Stomach Cancer Treatment
Conditions
Stomach Neoplasms
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
Botulinum Toxins, Injections, Stomach, Tomography, X-Ray Computed
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Botox
Type: Drug
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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:

1. Patients who have received 1.line and 2. line chemotherapy but no longer respond to such therapy.

2. Patients who, due to toxicity of chemotherapy, cannot be offered such treatment.

3. Patients who, after meticulous information about chemotherapy, still do not want such treatment.

4. Patients with performance status (ECOG) 0-2.

Exclusion criteria:

1. Known allergy to any of the components in Botox®

2. 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).

3. Pregnant or lactating women.

4. Another cancer disease that is not under control.

5. Another concomitant treatment for cancer.

6. Serious mental illness.

7. Performance status (ECOG) 3-4.
Location
Department of Gastrointestinal Surgery, St Olavs Hospital Trondheim University Hospital
Trondheim, Norway
Status: Recruiting
Contact: Jon Erik Grønbech, MD PhD - jon.e.gronbech@ntnu.no
Start Date
January 2013
Completion Date
February 2016
Sponsors
St. Olavs Hospital
Source
St. Olavs Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page