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

Double-Arm, Randomized Study of Botulinum Toxin Injection as a Pyloric Drainage Procedure for Minimally Invasive Esophagectomy (Phase II)

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.

Study Overview

• Status: Completed
• Conditions: Esophageal Carcinoma
• Intervention / Treatment: Other: Quality-of-Life Assessment; Procedure: Esophagectomy; Biological: Botulinum Toxin Type A

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (botulinum toxin type A, esophagectomy); Patients receive botulinum toxin type A injection IM while undergoing standard minimally invasive esophagectomy.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Procedure: Esophagectomy; Undergo esophagectomy; Other Names: excision of the esophagus; Biological: Botulinum Toxin Type A; Given IM; Other Names: Botox; OnabotulinumtoxinA; BTX-A; Xeomin; Dysport; IncobotulinumtoxinA; AbobotulinumtoxinA; Botox Cosmetic; Botulinum Toxin A; Botulinum A Toxin; Botulinum Neurotoxin Type A; EvabotulinumtoxinA; Onaclostox
Active Comparator: Arm II (esophagectomy); Patients undergo standard minimally invasive esophagectomy.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Procedure: Esophagectomy; Undergo esophagectomy; Other Names: excision of the esophagus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delayed Gastric Emptying Assessed Radiographically by Nuclear Medicine Emptying Study	Will be assessed using the intent-to-treat principle and a one-sided Cochran-Mantel-Haenszel (CMH) test.	Up to day 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delayed Gastric Emptying Assessed Radiographically by Gastrografin Swallow OR CT Esophagram	Delayed gastric emptying assessed Radiographically by Gastrografin Swallow OR CT Esophagram at day 7. Will be compared between treatment arms using the two-sided CMH exact test.	At day 7
Gastrointestinal and Nutritional Status Including Days to Resumption of Oral Feeding as Assessed by Dietician	The days to resumption of oral feeding are calculated based on return to a solid diet. Will be compared between treatment arms using the two sided independent-sample, stratified T-test.	Up to day 35
Hospital Length of Stay Attributed to Delayed Gastric Emptying	The total length of stay is calculated as the difference between the date of procedure and date of discharge. Will be compared between treatment arms using the two sided independent-sample, stratified T-test.	Up to 90 days
Secondary Procedure Due to Delayed Gastric Emptying	The rate of secondary procedures (within 90 days) will be compared between treatment arms using a one-sided CMH exact test.	Up to 90 days
Pulmonary Events Directly Related to Delayed Gastric Emptying as Assessed by Operating Surgeon	The rate of post-operative pulmonary events will be compared between treatment arms using the two-sided CMH exact test.	Up to day 90
Quality of Life Score as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 OES18	Will be compared between treatment arms using the two sided independent-sample, stratified T-test.	Up to day 90

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Investigators: Principal Investigator: Moshim Kukar, Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2016
• Primary Completion (Actual): January 28, 2022
• Study Completion (Actual): April 28, 2022

Study Registration Dates

• First Submitted: November 15, 2016
• First Submitted That Met QC Criteria: November 15, 2016
• First Posted (Estimate): November 17, 2016

Study Record Updates

• Last Update Posted (Actual): February 16, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA
• Other Study ID Numbers: I 283516 (Other Identifier: Roswell Park Cancer Institute); NCI-2016-01568 (Registry Identifier: CTRP (Clinical Trial Reporting Program))