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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01568 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 283516 | Other Identifier | Roswell Park Cancer Institute |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (botulinum toxin type A, esophagectomy) | Experimental | Patients receive botulinum toxin type A injection IM while undergoing standard minimally invasive esophagectomy. |
|
| Arm II (esophagectomy) | Active Comparator | Patients undergo standard minimally invasive esophagectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A | Biological | Given IM |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At day 7 |
| Gastrointestinal and Nutritional Status Including Days to Resumption of Oral Feeding as Assessed by Dietician |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moshim Kukar | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Botulinum Toxin Type A, Esophagectomy) | Patients receive botulinum toxin type A injection IM while undergoing standard minimally invasive esophagectomy. Botulinum Toxin Type A: Given IM Esophagectomy: Undergo esophagectomy Quality-of-Life Assessment: Ancillary studies |
| FG001 | Arm II (Esophagectomy) | Patients undergo standard minimally invasive esophagectomy. Esophagectomy: Undergo esophagectomy Quality-of-Life Assessment: Ancillary studies |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Botulinum Toxin Type A, Esophagectomy) | Patients receive botulinum toxin type A injection IM while undergoing standard minimally invasive esophagectomy. Botulinum Toxin Type A: Given IM Esophagectomy: Undergo esophagectomy Quality-of-Life Assessment: Ancillary studies |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | In Arm I, 2 patients withdrew prior to assessment of primary and secondary outcomes. | Posted | Count of Participants | Participants | Up to day 21 |
|
Adverse events were collected up to 90 days after surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (Botulinum Toxin Type A, Esophagectomy) | Patients receive botulinum toxin type A injection IM while undergoing standard minimally invasive esophagectomy. Botulinum Toxin Type A: Given IM Esophagectomy: Undergo esophagectomy Quality-of-Life Assessment: Ancillary studies |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kris Attwood | Roswell Park Comprehensive Cancer Center | 716-845-2300 | Kris.Attwood@roswellpark.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 3, 2021 | Jan 23, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C542869 | abobotulinumtoxinA |
| C545476 | incobotulinumtoxinA |
| D016629 | Esophagectomy |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Esophagectomy | Procedure | Undergo esophagectomy |
|
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
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. |
| 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. | 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. | 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. | 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. | Up to day 90 |
| Arm II (Esophagectomy) |
Patients undergo standard minimally invasive esophagectomy. Esophagectomy: Undergo esophagectomy Quality-of-Life Assessment: Ancillary studies |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Neoadjuvant Chemotherapy Status | Count of Participants | Participants |
|
| Self Reported Smoking Status | Count of Participants | Participants |
|
| Diabetes Status | Count of Participants | Participants |
|
Patients undergo standard minimally invasive esophagectomy.
Esophagectomy: Undergo esophagectomy
Quality-of-Life Assessment: Ancillary studies
|
|
|
| Secondary | 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. | 2 patients in Arm I withdrew prior to any assessments. | Posted | Count of Participants | Participants | At day 7 |
|
|
|
|
| Secondary | 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. | 2 patients in Arm I withdrew prior to study assessments. Data were not captured and is unavailable for 1 patient in Arm I and 4 patients in Arm II. | Posted | Mean | Standard Deviation | days | Up to day 35 |
|
|
|
|
| Secondary | 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. | 2 participants in arm I withdrew prior to any study assessments. Data were not captured and unavailable for 1 patient in Arm I and 1 patient in Arm II. | Posted | Mean | Standard Deviation | days | Up to 90 days |
|
|
|
|
| Secondary | 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. | 2 participants in arm I withdrew prior to any study assessments. Data were not captured and unavailable for 2 patients in Arm I and 2 patients in Arm II. | Posted | Count of Participants | Participants | Up to 90 days |
|
|
|
|
| Secondary | 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. | 2 participants in arm I withdrew prior to any study assessments. Data were not captured and unavailable for 1 patient in Arm I and 1 patient in Arm II. | Posted | Count of Participants | Participants | Up to day 90 |
|
|
|
|
| Secondary | 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. | The quality of life data were not captured. | Posted | Up to day 90 |
|
|
| 0 |
| 15 |
| 1 |
| 15 |
| 8 |
| 15 |
| EG001 | Arm II (Esophagectomy) | Patients undergo standard minimally invasive esophagectomy. Esophagectomy: Undergo esophagectomy Quality-of-Life Assessment: Ancillary studies | 0 | 17 | 2 | 17 | 10 | 17 |
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Postoperative thoracic procedure complication | Surgical and medical procedures | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Systematic Assessment |
|
| Chest pain | Cardiac disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Hypotension | Cardiac disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Weakness | General disorders | Systematic Assessment |
|
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| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |