Status:
COMPLETED
Botulinum Toxin for Stomach Cancer Treatment
Lead Sponsor:
St. Olavs Hospital
Collaborating Sponsors:
Norwegian University of Science and Technology
Conditions:
Stomach Neoplasms
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01822210
Start Date
January 1 2013
End Date
May 1 2016
Last Update
March 9 2018
Active Locations (1)
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1
Department of Gastrointestinal Surgery, St Olavs Hospital Trondheim University Hospital
Trondheim, Norway