Botulinum Toxin Type A in Preventing Complications After Surgery in Patients With Esophageal Cancer

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    50
  • sponsor
    Roswell Park Cancer Institute
Updated on 29 September 2021
esophagectomy
cancer
esophageal cancer

Summary

This randomized phase II trial studies how well botulinum toxin type A works in preventing complication after surgery in patients with esophageal cancer. Botulinum toxin type A may cause less complications of nausea and vomiting after surgery.

Description

PRIMARY OBJECTIVES:

I. Determine if intra-pyloric botulinum toxin type A (botulinum toxin) injection (Botox) during a minimally invasive esophagectomy decreases postoperative occurrence of delayed gastric emptying.

SECONDARY OBJECTIVES:

I. Determine if intra-pyloric botulinum toxin injection during a minimally invasive esophagectomy reduces the number of repeat procedures for delayed gastric emptying within 90 days.

II. Determine if intra-pyloric botulinum toxin injection during a minimally invasive esophagectomy decreases time to oral intake meeting 100% of nutritional requirements.

III. Determine if intra-pyloric botulinum toxin injection during a minimally invasive esophagectomy reduces the incidence of pulmonary complications directly related to delayed gastric emptying.

IV. Determine if intra-pyloric botulinum toxin injection during a minimally invasive esophagectomy reduces hospital length of stay related to delayed gastric emptying.

V. Determine if intra-pyloric botulinum toxin injection during a minimally invasive esophagectomy increases patient quality of life.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive botulinum toxin type A injection intramuscularly (IM) while undergoing standard minimally invasive esophagectomy.

ARM II: Patients undergo standard minimally invasive esophagectomy.

After completion of study treatment, patients are followed up at 2, 3-4, and 6-8 weeks, and at 90 days.

Details
Condition Esophageal Carcinoma, cancer of the esophagus, oesophageal carcinoma
Treatment quality-of-life assessment, Botulinum Toxin Type A, Esophagectomy
Clinical Study IdentifierNCT02965976
SponsorRoswell Park Cancer Institute
Last Modified on29 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Esophageal carcinoma, undergoing minimally invasive esophagectomy with intrathoracic anastomosis
Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria

Patients who have a history of gastrointestinal dysmotility or functional gastroparesis, including diabetic gastroparesis, central and peripheral nervous system disorders, renal failure, medication side effects, including chronic dependence of promotility agents, anticholinergic antispasmodic agents, or chronic narcotic use over 2 years due to non-cancer causes
Patients who have a history of previous gastric or duodenal surgery
Patients who have a history of duodenal ulcer or duodenal fibrosis
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Allergy to botulinum toxin and/or egg
Pregnant or nursing female participants
Unwilling or unable to follow protocol requirements
Any condition which in the investigator's opinion deems the participant an unsuitable candidate for study participation
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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