Esophageal CarcinomaPhase 2NCT02965976
Botulinum Toxin Type A in Preventing Complications After Surgery in Patients With Esophageal Cancer
A Phase 2 study testing Botulinum Toxin Type A, Esophagectomy and Quality-of-Life Assessment in people with Esophageal Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Carcinoma
- What is being tested?
- Botulinum Toxin Type A, Esophagectomy and Quality-of-Life Assessment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2016to 28 Apr 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: Double-Arm, Randomized Study of Botulinum Toxin Injection as a Pyloric Drainage Procedure for Minimally Invasive Esophagectomy (Phase II)
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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.
- Conditions
- Esophageal Carcinoma
- Being tested
- Botulinum Toxin Type A, Esophagectomy, Quality-of-Life Assessment
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type ABiological
Also called AbobotulinumtoxinA, Botox, Botox Cosmetic, Botulinum A Toxin
Given IM
EsophagectomyProcedure or surgery
Also called excision of the esophagus
Undergo esophagectomy
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (botulinum toxin type A, esophagectomy) | Experimental | Patients receive botulinum toxin type A injection IM while undergoing standard minimally invasive esophagectomy. Receives: Biological: Botulinum Toxin Type A; Procedure: Esophagectomy; Other: Quality-of-Life Assessment |
| Arm II (esophagectomy) | Active comparator | Patients undergo standard minimally invasive esophagectomy. Receives: Procedure: Esophagectomy; Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to day 21
Secondary outcomes (6)
Delayed Gastric Emptying Assessed Radiographically by Gastrografin Swallow OR CT Esophagram
Delayed gastric emptying assessed Radiographically by Gastrografin Swallow OR CT Esophagram at day 7. Will be compared between treatment arms using the two-sided CMH exact test.
Measured: At day 7
Gastrointestinal and Nutritional Status Including Days to Resumption of Oral Feeding as Assessed by Dietician
The days to resumption of oral feeding are calculated based on return to a solid diet. Will be compared between treatment arms using the two sided independent-sample, stratified T-test.
Measured: Up to day 35
Hospital Length of Stay Attributed to Delayed Gastric Emptying
The total length of stay is calculated as the difference between the date of procedure and date of discharge. Will be compared between treatment arms using the two sided independent-sample, stratified T-test.
Measured: Up to 90 days
Secondary Procedure Due to Delayed Gastric Emptying
The rate of secondary procedures (within 90 days) will be compared between treatment arms using a one-sided CMH exact test.
Measured: Up to 90 days
Pulmonary Events Directly Related to Delayed Gastric Emptying as Assessed by Operating Surgeon
The rate of post-operative pulmonary events will be compared between treatment arms using the two-sided CMH exact test.
Measured: Up to day 90
Quality of Life Score as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 OES18
Will be compared between treatment arms using the two sided independent-sample, stratified T-test.
Measured: Up to day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study start30 Dec 2016
- Primary completion28 Jan 2022
- Study completion28 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Esophageal CarcinomaStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moshim Kukar, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965976
- Sponsor's protocol ID
- I 283516
- Other IDs
- NCI-2016-01568, I 283516
- Status last verified
- Jan 2023
- First submitted
- 15 Nov 2016
- Last updated
- 16 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Arm, Randomized Study of Botulinum Toxin Injection as a Pyloric Drainage Procedure for Minimally Invasive Esophagectomy (Phase II)
- ClinicalTrials.gov ID
- NCT02965976
- Acronym / sponsor ID
- I 283516
- Conditions
- Esophageal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 30 Dec 2016 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Posted 16 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (botulinum toxin type A, esophagectomy) | Experimental | Biological: Botulinum Toxin Type A, Procedure: Esophagectomy, Other: Quality-of-Life AssessmentPatients receive botulinum toxin type A injection IM while undergoing standard minimally invasive esophagectomy. |
| Arm II (esophagectomy) | Active comparator | Procedure: Esophagectomy, Other: Quality-of-Life AssessmentPatients undergo standard minimally invasive esophagectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin Type AAlso: AbobotulinumtoxinA, Botox, Botox Cosmetic, Botulinum A ToxinGiven IM | Biological | Arm I (botulinum toxin type A, esophagectomy) |
| EsophagectomyAlso: excision of the esophagusUndergo esophagectomy | Procedure or surgery | Arm I (botulinum toxin type A, esophagectomy), Arm II (esophagectomy) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (botulinum toxin type A, esophagectomy), Arm II (esophagectomy) |
Primary outcome
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.
6 secondary outcomes
Delayed Gastric Emptying Assessed Radiographically by Gastrografin Swallow OR CT Esophagram
Time frame: At day 7
Gastrointestinal and Nutritional Status Including Days to Resumption of Oral Feeding as Assessed by Dietician
Time frame: Up to day 35
Hospital Length of Stay Attributed to Delayed Gastric Emptying
Time frame: Up to 90 days
Secondary Procedure Due to Delayed Gastric Emptying
Time frame: Up to 90 days
Pulmonary Events Directly Related to Delayed Gastric Emptying as Assessed by Operating Surgeon
Time frame: Up to day 90
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moshim Kukar principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botulinum Toxin Type A, Esophagectomy and Quality-of-Life Assessment in people with Esophageal Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delayed Gastric Emptying Assessed Radiographically by Nuclear Medicine Emptying Study (time frame: Up to day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.