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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-30

Study Completion Date

2022-04-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Esophageal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Arm I (botulinum toxin type A, esophagectomy)

Patients receive botulinum toxin type A injection IM while undergoing standard minimally invasive esophagectomy.

Group Type EXPERIMENTAL

Botulinum Toxin Type A

Intervention Type BIOLOGICAL

Given IM

Esophagectomy

Intervention Type PROCEDURE

Undergo esophagectomy

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Arm II (esophagectomy)

Patients undergo standard minimally invasive esophagectomy.

Group Type ACTIVE_COMPARATOR

Esophagectomy

Intervention Type PROCEDURE

Undergo esophagectomy

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Interventions

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Botulinum Toxin Type A

Given IM

Intervention Type BIOLOGICAL

Esophagectomy

Undergo esophagectomy

Intervention Type PROCEDURE

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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AbobotulinumtoxinA Botox Botox Cosmetic Botulinum A Toxin Botulinum Neurotoxin Type A Botulinum Toxin A BTX-A Dysport EvabotulinumtoxinA IncobotulinumtoxinA OnabotulinumtoxinA Onaclostox Xeomin excision of the esophagus Quality of Life Assessment

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No