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Botulinum Toxin for Stomach Cancer Treatment

Primary Purpose

Stomach Neoplasms

Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Botox
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasms focused on measuring Botulinum Toxins, Injections, Stomach, Tomography, X-Ray Computed

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Gastrointestinal Surgery, St Olavs Hospital Trondheim University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Botox

Arm Description

Injection of Botox in the tumor and surrounding stomach wall.

Outcomes

Primary Outcome Measures

Change of tumor volume in the stomach.
Change measured with a standardized CT protocol (Thickness of the stomach wall and diameter of the tumor).
Change of tumor volume in the stomach.
Change measured with a standardized CT protocol (Thickness of the stomach wall and diameter of the tumor).

Secondary Outcome Measures

Toxicity
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Toxicity
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
performance status
ECOG scale
performance status
ECOG scale
performance status
ECOG scale

Full Information

First Posted
March 21, 2013
Last Updated
March 8, 2018
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT01822210
Brief Title
Botulinum Toxin for Stomach Cancer Treatment
Official Title
Botulinum Toxin (BOTOX) for Stomach Cancer Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
Keywords
Botulinum Toxins, Injections, Stomach, Tomography, X-Ray Computed

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botox
Arm Type
Experimental
Arm Description
Injection of Botox in the tumor and surrounding stomach wall.
Intervention Type
Drug
Intervention Name(s)
Botox
Other Intervention Name(s)
Botulinum toxin
Intervention Description
injection by gastroscopy (100 Allergen units)
Primary Outcome Measure Information:
Title
Change of tumor volume in the stomach.
Description
Change measured with a standardized CT protocol (Thickness of the stomach wall and diameter of the tumor).
Time Frame
Baseline and 8 weeks
Title
Change of tumor volume in the stomach.
Description
Change measured with a standardized CT protocol (Thickness of the stomach wall and diameter of the tumor).
Time Frame
8 weeks and 20 weeks
Secondary Outcome Measure Information:
Title
Toxicity
Description
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time Frame
2 weeks
Title
Toxicity
Description
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time Frame
8 weeks
Title
performance status
Description
ECOG scale
Time Frame
2 weeks
Title
performance status
Description
ECOG scale
Time Frame
8 weeks
Title
performance status
Description
ECOG scale
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Erik Grønbech, MD. PhD.
Organizational Affiliation
St. Olavs Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastrointestinal Surgery, St Olavs Hospital Trondheim University Hospital
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Citations:
Citation
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/S0016-5085(16)34227-5
Results Reference
result

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Botulinum Toxin for Stomach Cancer Treatment

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