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

Primary Purpose

Esophageal Carcinoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Botulinum Toxin Type A
Esophagectomy
Quality-of-Life Assessment
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Esophageal Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (botulinum toxin type A, esophagectomy)

Arm II (esophagectomy)

Arm Description

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

Patients undergo standard minimally invasive esophagectomy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
November 15, 2016
Last Updated
January 23, 2023
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02965976
Brief Title
Botulinum Toxin Type A in Preventing Complications After Surgery in Patients With Esophageal Cancer
Official Title
Double-Arm, Randomized Study of Botulinum Toxin Injection as a Pyloric Drainage Procedure for Minimally Invasive Esophagectomy (Phase II)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 30, 2016 (Actual)
Primary Completion Date
January 28, 2022 (Actual)
Study Completion Date
April 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Carcinoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (botulinum toxin type A, esophagectomy)
Arm Type
Experimental
Arm Description
Patients receive botulinum toxin type A injection IM while undergoing standard minimally invasive esophagectomy.
Arm Title
Arm II (esophagectomy)
Arm Type
Active Comparator
Arm Description
Patients undergo standard minimally invasive esophagectomy.
Intervention Type
Biological
Intervention Name(s)
Botulinum Toxin Type A
Other Intervention Name(s)
AbobotulinumtoxinA, Botox, Botox Cosmetic, Botulinum A Toxin, Botulinum Neurotoxin Type A, Botulinum Toxin A, BTX-A, Dysport, EvabotulinumtoxinA, IncobotulinumtoxinA, OnabotulinumtoxinA, Onaclostox, Xeomin
Intervention Description
Given IM
Intervention Type
Procedure
Intervention Name(s)
Esophagectomy
Other Intervention Name(s)
excision of the esophagus
Intervention Description
Undergo esophagectomy
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Delayed Gastric Emptying Assessed Radiographically by Nuclear Medicine Emptying Study
Description
Will be assessed using the intent-to-treat principle and a one-sided Cochran-Mantel-Haenszel (CMH) test.
Time Frame
Up to day 21
Secondary Outcome Measure Information:
Title
Delayed Gastric Emptying Assessed Radiographically by Gastrografin Swallow OR CT Esophagram
Description
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.
Time Frame
At day 7
Title
Gastrointestinal and Nutritional Status Including Days to Resumption of Oral Feeding as Assessed by Dietician
Description
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.
Time Frame
Up to day 35
Title
Hospital Length of Stay Attributed to Delayed Gastric Emptying
Description
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.
Time Frame
Up to 90 days
Title
Secondary Procedure Due to Delayed Gastric Emptying
Description
The rate of secondary procedures (within 90 days) will be compared between treatment arms using a one-sided CMH exact test.
Time Frame
Up to 90 days
Title
Pulmonary Events Directly Related to Delayed Gastric Emptying as Assessed by Operating Surgeon
Description
The rate of post-operative pulmonary events will be compared between treatment arms using the two-sided CMH exact test.
Time Frame
Up to day 90
Title
Quality of Life Score as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 OES18
Description
Will be compared between treatment arms using the two sided independent-sample, stratified T-test.
Time Frame
Up to day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moshim Kukar
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States

12. IPD Sharing Statement

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

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