Phase 2
N=32
Botulinum Toxin Type A in Preventing Complications After Surgery in Patients With Esophageal Cancer
Esophageal Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT02965976 ↗Enrolled (actual)
32
Serious AEs
9.4%
Results posted
Feb 2023
Primary outcome: Primary: Delayed Gastric Emptying Assessed Radiographically by Nuclear Medicine Emptying Study — 12; 14; 1; 3 Participants — p=0.773
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Botulinum Toxin Type A (Biological); Esophagectomy (Procedure); Quality-of-Life Assessment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Roswell Park Cancer Institute
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Delayed Gastric Emptying Assessed Radiographically by Nuclear Medicine Emptying Study |
12; 14; 1; 3 | 0.773 |
| SECONDARY Delayed Gastric Emptying Assessed Radiographically by Gastrografin Swallow OR CT Esophagram |
12; 14; 1; 3 | 0.773 |
| SECONDARY Gastrointestinal and Nutritional Status Including Days to Resumption of Oral Feeding as Assessed by Dietician |
22.6; 27 | 0.368 |
| SECONDARY Hospital Length of Stay Attributed to Delayed Gastric Emptying |
7.9; 8.1 | 0.987 |
| SECONDARY Secondary Procedure Due to Delayed Gastric Emptying |
1; 0; 10; 15 | 0.423 |
| SECONDARY Pulmonary Events Directly Related to Delayed Gastric Emptying as Assessed by Operating Surgeon |
3; 3; 9; 13 | 1.000 |
| SECONDARY Quality of Life Score as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 OES18 |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02965976). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.