Botulinum Toxin for Stomach Cancer Treatment
- Registration Number
- NCT01822210
- Lead Sponsor
- St. Olavs Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Botox Botox Injection of Botox in the tumor and surrounding stomach wall.
- Primary Outcome Measures
Name Time Method Change of tumor volume in the stomach. 8 weeks and 20 weeks Change measured with a standardized CT protocol (Thickness of the stomach wall and diameter of the tumor).
- Secondary Outcome Measures
Name Time Method Toxicity 8 weeks Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
performance status 20 weeks ECOG scale
Trial Locations
- Locations (1)
Department of Gastrointestinal Surgery, St Olavs Hospital Trondheim University Hospital
🇳🇴Trondheim, Norway