Clinical trial NCT01822210: Botulinum Toxin for Stomach Cancer Treatment
Official title: Botulinum Toxin (BOTOX) for Stomach Cancer Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stomach Neoplasms
Keywords: Botulinum Toxins
Injections
Stomach
Tomography, X-Ray Computed
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2013-04-02
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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:

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.

Primary outcomes:
measure: Change of tumor volume in the stomach.
timeFrame: Baseline and 8 weeks
measure: Change of tumor volume in the stomach.
timeFrame: 8 weeks and 20 weeks
Secondary outcomes:
measure: Toxicity
timeFrame: 2 weeks
measure: Toxicity
timeFrame: 8 weeks
measure: performance status
timeFrame: 2 weeks
measure: performance status
timeFrame: 8 weeks
measure: performance status
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Gastrointestinal Surgery, St Olavs Hospital Trondheim University Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Jon Erik Grønbech, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
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