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

NCT02965976 | Completed Phase 2 Results DMC

• 2 other identifiers: I 283516NCI-2016-01568
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Delayed Gastric Emptying Assessed Radiographically by Gastrografin Swallow OR CT Esophagram

  At day 7

• Gastrointestinal and Nutritional Status Including Days to Resumption of Oral Feeding as Assessed by Dietician

  Up to day 35

• Hospital Length of Stay Attributed to Delayed Gastric Emptying

  Up to 90 days

• Secondary Procedure Due to Delayed Gastric Emptying

  Up to 90 days

• Pulmonary Events Directly Related to Delayed Gastric Emptying as Assessed by Operating Surgeon

  Up to day 90

Study Arms (2)

Arm I (botulinum toxin type A, esophagectomy)

EXPERIMENTAL

Patients receive botulinum toxin type A injection IM while undergoing standard minimally invasive esophagectomy.

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

Arm II (esophagectomy)

ACTIVE COMPARATOR

Patients undergo standard minimally invasive esophagectomy.

Procedure: Esophagectomy; Other: Quality-of-Life Assessment

Interventions

Botulinum Toxin Type A BIOLOGICAL

Given IM

Also known as: AbobotulinumtoxinA, Botox, Botox Cosmetic, Botulinum A Toxin, Botulinum Neurotoxin Type A, Botulinum Toxin A, BTX-A, Dysport, EvabotulinumtoxinA, IncobotulinumtoxinA, OnabotulinumtoxinA, Onaclostox, Xeomin

Arm I (botulinum toxin type A, esophagectomy)

Esophagectomy PROCEDURE

Undergo esophagectomy

Also known as: excision of the esophagus

Arm I (botulinum toxin type A, esophagectomy); Arm II (esophagectomy)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (botulinum toxin type A, esophagectomy); Arm II (esophagectomy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA; Esophagectomy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Digestive System Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Kris Attwood
• Organization: Roswell Park Comprehensive Cancer Center

Kris.Attwood@roswellpark.org

716-845-2300

Study Officials

• Moshim Kukar

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: November 17, 2016
• Study Start: December 30, 2016
• Primary Completion: January 28, 2022
• Study Completion: April 28, 2022
• Last Updated: February 16, 2023
• Results First Posted: February 16, 2023

Record last verified: 2023-01

Locations

US (1)