drugset / Trial / NCT02965976

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

NCT02965976 ↗

Phase 2 Completed 33 enrolled Roswell Park Cancer Institute
RandomizedParallel-groupDouble-blindSupportive care

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.

Timeline

Start
2016-12-30
Primary completion
2022-01-28
Completion
2022-04-28

Outcome

Missed primary endpoint

registry analysis (superiority test); Arm I (Botulinum Toxin Type A, Esophagectomy) vs Arm II (Esophagectomy); p = 0.773; Cochran-Mantel-Haenszel NCT02965976 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic — Intramuscular

Indications