Clinical trial NCT02965976: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Carcinoma
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2016-11-17
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Delayed Gastric Emptying Assessed Radiographically by Nuclear Medicine Emptying Study
timeFrame: Up to day 21
Secondary outcomes:
measure: Delayed Gastric Emptying Assessed Radiographically by Gastrografin Swallow OR CT Esophagram
timeFrame: At day 7
measure: Gastrointestinal and Nutritional Status Including Days to Resumption of Oral Feeding as Assessed by Dietician
timeFrame: Up to day 35
measure: Hospital Length of Stay Attributed to Delayed Gastric Emptying
timeFrame: Up to 90 days
measure: Secondary Procedure Due to Delayed Gastric Emptying
timeFrame: Up to 90 days
measure: Pulmonary Events Directly Related to Delayed Gastric Emptying as Assessed by Operating Surgeon
timeFrame: Up to day 90
measure: Quality of Life Score as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 OES18
timeFrame: Up to day 90
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Moshim Kukar
role: PRINCIPAL_INVESTIGATOR
References: