Botulinum Toxin for Stomach Cancer Treatment

March 8, 2018 updated by: St. Olavs Hospital

Botulinum Toxin (BOTOX) for Stomach Cancer Treatment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Botox
Injection of Botox in the tumor and surrounding stomach wall.
Drug: Botox
injection by gastroscopy (100 Allergen units)
Other Names:
  • Botulinum toxin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of tumor volume in the stomach.
Time Frame: Baseline and 8 weeks
Change measured with a standardized CT protocol (Thickness of the stomach wall and diameter of the tumor).
Baseline and 8 weeks
Change of tumor volume in the stomach.
Time Frame: 8 weeks and 20 weeks
Change measured with a standardized CT protocol (Thickness of the stomach wall and diameter of the tumor).
8 weeks and 20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicity
Time Frame: 2 weeks
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
2 weeks
Toxicity
Time Frame: 8 weeks
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
8 weeks
performance status
Time Frame: 2 weeks
ECOG scale
2 weeks
performance status
Time Frame: 8 weeks
ECOG scale
8 weeks
performance status
Time Frame: 20 weeks
ECOG scale
20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Olavs Hospital

Collaborators

Norwegian University of Science and Technology

Investigators

  • Principal Investigator: Jon Erik Grønbech, MD. PhD., St. Olavs Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2013

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

March 21, 2013

First Submitted That Met QC Criteria

March 27, 2013

First Posted (ESTIMATE)

April 2, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2018

Last Update Submitted That Met QC Criteria

March 8, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • StOlav2205
  • 2012-002493-31 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stomach Neoplasms

Clinical Trials on Botox

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe