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

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ClinicalTrials.gov Identifier: NCT02965976
Recruitment Status : Recruiting
First Posted : November 17, 2016
Last Update Posted : November 2, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Esophageal Carcinoma Biological: Botulinum Toxin Type A Procedure: Esophagectomy Other: Quality-of-Life Assessment Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Double-Arm, Randomized Study of Botulinum Toxin Injection as a Pyloric Drainage Procedure for Minimally Invasive Esophagectomy (Phase II)
Actual Study Start Date : December 30, 2016
Estimated Primary Completion Date : October 5, 2020
Estimated Study Completion Date : October 5, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm I (botulinum toxin type A, esophagectomy)
Patients receive botulinum toxin type A injection IM while undergoing standard minimally invasive esophagectomy.
Biological: Botulinum Toxin Type A
Given IM
Other Names:
  • AbobotulinumtoxinA
  • Botox
  • Botox Cosmetic
  • Botulinum A Toxin
  • Botulinum Neurotoxin Type A
  • Botulinum Toxin A
  • BTX-A
  • Dysport
  • EvabotulinumtoxinA
  • IncobotulinumtoxinA
  • OnabotulinumtoxinA
  • Onaclostox
  • Xeomin

Procedure: Esophagectomy
Undergo esophagectomy
Other Name: excision of the esophagus

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Active Comparator: Arm II (esophagectomy)
Patients undergo standard minimally invasive esophagectomy.
Procedure: Esophagectomy
Undergo esophagectomy
Other Name: excision of the esophagus

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment




Primary Outcome Measures :
  1. Delayed gastric emptying assessed radiographically by nuclear medicine emptying study [ Time Frame: 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 :
  1. Delayed gastric emptying assessed radiographically by gastrografin swallow [ Time Frame: At day 7 ]
    Will be compared between treatment arms using the two-sided CMH exact test.

  2. Gastrointestinal and nutritional status including days to resumption of oral feeding as assessed by dietician [ Time Frame: Up to day 35 ]
    Will be compared between treatment arms using the two sided independent-sample, stratified T-test.

  3. Hospital length of stay attributed to delayed gastric emptying [ Time Frame: Up to 90 days ]
    Will be compared between treatment arms using the two sided independent-sample, stratified T-test.

  4. Number of secondary procedures due to delayed gastric emptying [ Time Frame: Up to 90 days ]
    Will be compared between treatment arms using a one-sided CMH exact test.

  5. Pulmonary events directly related to delayed gastric emptying as assessed by operating surgeon [ Time Frame: Up to day 90 ]
    Will be compared between treatment arms using the two-sided CMH exact test.

  6. Quality of life score as assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 OES18 [ Time Frame: Up to day 90 ]
    Will be compared between treatment arms using the two sided independent-sample, stratified T-test.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Esophageal carcinoma, undergoing minimally invasive esophagectomy with intrathoracic anastomosis
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
  • Participant or legal representative 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 daily narcotic use
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02965976


Locations
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United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Roswell Park    877-275-7724    ASKRPCI@RoswellPark.org   
Principal Investigator: Moshim Kukar         
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Moshim Kukar Roswell Park Cancer Institute

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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT02965976     History of Changes
Other Study ID Numbers: I 283516
NCI-2016-01568 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 283516 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
incobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents