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

Phase 2

Completed

Conditions: Esophageal Carcinoma

Interventions: Biological: Botulinum Toxin Type A
Other: Quality-of-Life Assessment
Procedure: Esophagectomy

Registration Number: NCT02965976

Lead Sponsor: Roswell Park Cancer Institute

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 33

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (esophagectomy)	Quality-of-Life Assessment	Patients undergo standard minimally invasive esophagectomy.
Arm I (botulinum toxin type A, esophagectomy)	Esophagectomy	Patients receive botulinum toxin type A injection IM while undergoing standard minimally invasive esophagectomy.
Arm I (botulinum toxin type A, esophagectomy)	Quality-of-Life Assessment	Patients receive botulinum toxin type A injection IM while undergoing standard minimally invasive esophagectomy.
Arm I (botulinum toxin type A, esophagectomy)	Botulinum Toxin Type A	Patients receive botulinum toxin type A injection IM while undergoing standard minimally invasive esophagectomy.
Arm II (esophagectomy)	Esophagectomy	Patients undergo standard minimally invasive esophagectomy.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal and Nutritional Status Including Days to Resumption of Oral Feeding as Assessed by Dietician	Up to day 35	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.
Secondary Procedure Due to Delayed Gastric Emptying	Up to 90 days	The rate of secondary procedures (within 90 days) will be compared between treatment arms using a one-sided CMH exact test.
Delayed Gastric Emptying Assessed Radiographically by Gastrografin Swallow OR CT Esophagram	At day 7	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.
Hospital Length of Stay Attributed to Delayed Gastric Emptying	Up to 90 days	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.
Pulmonary Events Directly Related to Delayed Gastric Emptying as Assessed by Operating Surgeon	Up to day 90	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	Up to day 90	Will be compared between treatment arms using the two sided independent-sample, stratified T-test.