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

Study Overview
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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.

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.

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

Conditions
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Esophageal Carcinoma

Intervention / Treatment
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* Biological: Botulinum Toxin Type A
* Procedure: Esophagectomy
* Other: Quality-of-Life Assessment


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (botulinum toxin type A, esophagectomy)<br>Patients receive botulinum toxin type A injection IM while undergoing standard minimally invasive esophagectomy. | Biological: Botulinum Toxin Type A<br>* Given IM<br>* Other names: Xeomin;Procedure: Esophagectomy<br>* Undergo esophagectomy<br>* Other names: excision of the esophagus;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;|
| Active Comparator: Arm II (esophagectomy)<br>Patients undergo standard minimally invasive esophagectomy. | Procedure: Esophagectomy<br>* Undergo esophagectomy<br>* Other names: excision of the esophagus;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;|

What is the study measuring?
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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 |