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Completed

NCT Number: NCT01822210

Botulinum Toxin 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.

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Key information

Conditions

Stomach Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Gastrointestinal Surgery, St Olavs Hospital Trondheim University Hospital

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Botox

Drug

injection by gastroscopy (100 Allergen units)

Other names: Botulinum toxin

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. Toxicity

    Time frame: 2 weeks

    Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  2. Toxicity

    Time frame: 8 weeks

    Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  3. performance status

    Time frame: 2 weeks

    ECOG scale

  4. performance status

    Time frame: 8 weeks

    ECOG scale

  5. performance status

    Time frame: 20 weeks

    ECOG scale

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian University of Science and Technology

Registry information

Official study title

Botulinum Toxin (BOTOX) for Stomach Cancer Treatment

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Apr 2, 2013
Registry last updated
Mar 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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