Botulinum Toxin for Stomach Cancer Treatment

Stomach Neoplasms Clinical Trial

Official title:

Botulinum Toxin (BOTOX) for Stomach Cancer Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01822210
• Other study ID #: StOlav2205
• Secondary ID: 2012-002493-31
• Status: Completed
• Phase: Phase 2
• First received: March 21, 2013
• Last updated: March 8, 2018
• Start date: January 2013
• Est. completion date: May 2016

Study information

• Verified date: March 2018
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Drug:
• Botox
injection by gastroscopy (100 Allergen units)

Locations

Country	Name	City	State
Norway	Department of Gastrointestinal Surgery, St Olavs Hospital Trondheim University Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Andersen G, Zhao CM, Cai X, Rabben HL, Fox JG, Wang TC, Chen D, Gronbech JE. Tu1418 Intragastric Injection of Botulinum Toxin a to Treat Gastric Cancer: An Open-Label Phase II Clinical Trial. Gastroenterology 150: S1251-1252, 2016 https://doi.org/10.1016/

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Toxicity	Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	2 weeks
Secondary	Toxicity	Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	8 weeks
Secondary	performance status	ECOG scale	2 weeks
Secondary	performance status	ECOG scale	8 weeks
Secondary	performance status	ECOG scale	20 weeks