Trial Outcomes & Findings for Botulinum Toxin Type A in Preventing Complications After Surgery in Patients With Esophageal Cancer (NCT NCT02965976)

NCT ID: NCT02965976

Last Updated: 2023-02-16

Results Overview

Will be assessed using the intent-to-treat principle and a one-sided Cochran-Mantel-Haenszel (CMH) test.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

Up to day 21

Results posted on

2023-02-16

Participant Flow

Participant milestones

Participant milestones
Measure	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	Arm II (Esophagectomy) Patients undergo standard minimally invasive esophagectomy. Esophagectomy: Undergo esophagectomy Quality-of-Life Assessment: Ancillary studies
Overall Study STARTED	15	17
Overall Study COMPLETED	13	17
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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	Arm II (Esophagectomy) Patients undergo standard minimally invasive esophagectomy. Esophagectomy: Undergo esophagectomy Quality-of-Life Assessment: Ancillary studies
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Botulinum Toxin Type A, Esophagectomy) n=15 Participants 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	Arm II (Esophagectomy) n=17 Participants Patients undergo standard minimally invasive esophagectomy. Esophagectomy: Undergo esophagectomy Quality-of-Life Assessment: Ancillary studies	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Age, Continuous	64.2 years STANDARD_DEVIATION 8.0 • n=5 Participants	61.2 years STANDARD_DEVIATION 11.0 • n=7 Participants	62.2 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	17 participants n=7 Participants	32 participants n=5 Participants
Neoadjuvant Chemotherapy Status Yes	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Neoadjuvant Chemotherapy Status No	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Self Reported Smoking Status Never Smoked	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Self Reported Smoking Status Former Smoker	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Self Reported Smoking Status Current Smoker	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Diabetes Status Yes	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Diabetes Status No	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to day 21

Population: In Arm I, 2 patients withdrew prior to assessment of primary and secondary outcomes.

Will be assessed using the intent-to-treat principle and a one-sided Cochran-Mantel-Haenszel (CMH) test.

Outcome measures

Outcome measures
Measure	Arm I (Botulinum Toxin Type A, Esophagectomy) n=13 Participants 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	Arm II (Esophagectomy) n=17 Participants Patients undergo standard minimally invasive esophagectomy. Esophagectomy: Undergo esophagectomy Quality-of-Life Assessment: Ancillary studies
Delayed Gastric Emptying Assessed Radiographically by Nuclear Medicine Emptying Study Delayed Gastric Emptying	12 Participants	14 Participants
Delayed Gastric Emptying Assessed Radiographically by Nuclear Medicine Emptying Study No Delayed Gastric Emptying	1 Participants	3 Participants

SECONDARY outcome

Timeframe: At day 7

Population: 2 patients in Arm I withdrew prior to any assessments.

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.

Outcome measures

Outcome measures
Measure	Arm I (Botulinum Toxin Type A, Esophagectomy) n=13 Participants 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	Arm II (Esophagectomy) n=17 Participants Patients undergo standard minimally invasive esophagectomy. Esophagectomy: Undergo esophagectomy Quality-of-Life Assessment: Ancillary studies
Delayed Gastric Emptying Assessed Radiographically by Gastrografin Swallow OR CT Esophagram Delayed gastric Emptying	12 Participants	14 Participants
Delayed Gastric Emptying Assessed Radiographically by Gastrografin Swallow OR CT Esophagram No Delayed Gastric Emptying	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to day 35

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Arm I (Botulinum Toxin Type A, Esophagectomy) n=10 Participants 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	Arm II (Esophagectomy) n=13 Participants Patients undergo standard minimally invasive esophagectomy. Esophagectomy: Undergo esophagectomy Quality-of-Life Assessment: Ancillary studies
Gastrointestinal and Nutritional Status Including Days to Resumption of Oral Feeding as Assessed by Dietician	22.6 days Standard Deviation 4.7	27 days Standard Deviation 16.2

SECONDARY outcome

Timeframe: Up to 90 days

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Arm I (Botulinum Toxin Type A, Esophagectomy) n=10 Participants 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	Arm II (Esophagectomy) n=16 Participants Patients undergo standard minimally invasive esophagectomy. Esophagectomy: Undergo esophagectomy Quality-of-Life Assessment: Ancillary studies
Hospital Length of Stay Attributed to Delayed Gastric Emptying	7.9 days Standard Deviation 4.2	8.1 days Standard Deviation 1.9

SECONDARY outcome

Timeframe: Up to 90 days

Population: 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.

The rate of secondary procedures (within 90 days) will be compared between treatment arms using a one-sided CMH exact test.

Outcome measures

Outcome measures
Measure	Arm I (Botulinum Toxin Type A, Esophagectomy) n=11 Participants 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	Arm II (Esophagectomy) n=15 Participants Patients undergo standard minimally invasive esophagectomy. Esophagectomy: Undergo esophagectomy Quality-of-Life Assessment: Ancillary studies
Secondary Procedure Due to Delayed Gastric Emptying Reoperation	1 Participants	0 Participants
Secondary Procedure Due to Delayed Gastric Emptying No Reoperation	10 Participants	15 Participants

SECONDARY outcome

Timeframe: Up to day 90

Population: 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.

The rate of post-operative pulmonary events will be compared between treatment arms using the two-sided CMH exact test.

Outcome measures

Outcome measures
Measure	Arm I (Botulinum Toxin Type A, Esophagectomy) n=12 Participants 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	Arm II (Esophagectomy) n=16 Participants Patients undergo standard minimally invasive esophagectomy. Esophagectomy: Undergo esophagectomy Quality-of-Life Assessment: Ancillary studies
Pulmonary Events Directly Related to Delayed Gastric Emptying as Assessed by Operating Surgeon Pulmonary Complication	3 Participants	3 Participants
Pulmonary Events Directly Related to Delayed Gastric Emptying as Assessed by Operating Surgeon No Pulmonary Complication	9 Participants	13 Participants

SECONDARY outcome

Timeframe: Up to day 90

Population: The quality of life data were not captured.

Will be compared between treatment arms using the two sided independent-sample, stratified T-test.

Outcome measures

Outcome data not reported

Adverse Events

Arm I (Botulinum Toxin Type A, Esophagectomy)

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Arm II (Esophagectomy)

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm I (Botulinum Toxin Type A, Esophagectomy) n=15 participants at risk 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	Arm II (Esophagectomy) n=17 participants at risk Patients undergo standard minimally invasive esophagectomy. Esophagectomy: Undergo esophagectomy Quality-of-Life Assessment: Ancillary studies
Gastrointestinal disorders Vomiting	6.7% 1/15 • Number of events 2 • Adverse events were collected up to 90 days after surgery.	0.00% 0/17 • Adverse events were collected up to 90 days after surgery.
Cardiac disorders Atrial fibrillation	0.00% 0/15 • Adverse events were collected up to 90 days after surgery.	5.9% 1/17 • Number of events 1 • Adverse events were collected up to 90 days after surgery.
Surgical and medical procedures Postoperative thoracic procedure complication	0.00% 0/15 • Adverse events were collected up to 90 days after surgery.	5.9% 1/17 • Number of events 1 • Adverse events were collected up to 90 days after surgery.

Other adverse events

Additional Information

Kris Attwood

Roswell Park Comprehensive Cancer Center

Phone: 716-845-2300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm I (Botulinum Toxin Type A, Esophagectomy) n=15 participants at risk 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	Arm II (Esophagectomy) n=17 participants at risk Patients undergo standard minimally invasive esophagectomy. Esophagectomy: Undergo esophagectomy Quality-of-Life Assessment: Ancillary studies
Gastrointestinal disorders Abdominal pain	6.7% 1/15 • Number of events 1 • Adverse events were collected up to 90 days after surgery.	5.9% 1/17 • Number of events 1 • Adverse events were collected up to 90 days after surgery.
Metabolism and nutrition disorders Anorexia	6.7% 1/15 • Number of events 1 • Adverse events were collected up to 90 days after surgery.	5.9% 1/17 • Number of events 1 • Adverse events were collected up to 90 days after surgery.
Respiratory, thoracic and mediastinal disorders Aspiration	13.3% 2/15 • Number of events 2 • Adverse events were collected up to 90 days after surgery.	5.9% 1/17 • Number of events 1 • Adverse events were collected up to 90 days after surgery.
Respiratory, thoracic and mediastinal disorders Atelectasis	13.3% 2/15 • Number of events 2 • Adverse events were collected up to 90 days after surgery.	23.5% 4/17 • Number of events 4 • Adverse events were collected up to 90 days after surgery.
Cardiac disorders Atrial fibrillation	0.00% 0/15 • Adverse events were collected up to 90 days after surgery.	17.6% 3/17 • Number of events 4 • Adverse events were collected up to 90 days after surgery.
Musculoskeletal and connective tissue disorders Back pain	6.7% 1/15 • Number of events 1 • Adverse events were collected up to 90 days after surgery.	5.9% 1/17 • Number of events 1 • Adverse events were collected up to 90 days after surgery.
Gastrointestinal disorders Bloating	0.00% 0/15 • Adverse events were collected up to 90 days after surgery.	11.8% 2/17 • Number of events 2 • Adverse events were collected up to 90 days after surgery.
Cardiac disorders Chest pain	0.00% 0/15 • Adverse events were collected up to 90 days after surgery.	11.8% 2/17 • Number of events 2 • Adverse events were collected up to 90 days after surgery.
Gastrointestinal disorders Constipation	6.7% 1/15 • Number of events 1 • Adverse events were collected up to 90 days after surgery.	5.9% 1/17 • Number of events 1 • Adverse events were collected up to 90 days after surgery.
Respiratory, thoracic and mediastinal disorders Cough	26.7% 4/15 • Number of events 4 • Adverse events were collected up to 90 days after surgery.	35.3% 6/17 • Number of events 8 • Adverse events were collected up to 90 days after surgery.
Gastrointestinal disorders Diarrhea	6.7% 1/15 • Number of events 1 • Adverse events were collected up to 90 days after surgery.	29.4% 5/17 • Number of events 5 • Adverse events were collected up to 90 days after surgery.
General disorders Fatigue	20.0% 3/15 • Number of events 4 • Adverse events were collected up to 90 days after surgery.	23.5% 4/17 • Number of events 4 • Adverse events were collected up to 90 days after surgery.
Cardiac disorders Hypotension	13.3% 2/15 • Number of events 2 • Adverse events were collected up to 90 days after surgery.	0.00% 0/17 • Adverse events were collected up to 90 days after surgery.
Gastrointestinal disorders Nausea	20.0% 3/15 • Number of events 3 • Adverse events were collected up to 90 days after surgery.	23.5% 4/17 • Number of events 4 • Adverse events were collected up to 90 days after surgery.
Respiratory, thoracic and mediastinal disorders Pleural effusion	20.0% 3/15 • Number of events 3 • Adverse events were collected up to 90 days after surgery.	17.6% 3/17 • Number of events 3 • Adverse events were collected up to 90 days after surgery.
Respiratory, thoracic and mediastinal disorders Pneumothorax	13.3% 2/15 • Number of events 2 • Adverse events were collected up to 90 days after surgery.	29.4% 5/17 • Number of events 5 • Adverse events were collected up to 90 days after surgery.
Respiratory, thoracic and mediastinal disorders Shortness of breath	0.00% 0/15 • Adverse events were collected up to 90 days after surgery.	17.6% 3/17 • Number of events 3 • Adverse events were collected up to 90 days after surgery.
Renal and urinary disorders Urinary retention	13.3% 2/15 • Number of events 2 • Adverse events were collected up to 90 days after surgery.	5.9% 1/17 • Number of events 1 • Adverse events were collected up to 90 days after surgery.
Gastrointestinal disorders Vomiting	0.00% 0/15 • Adverse events were collected up to 90 days after surgery.	17.6% 3/17 • Number of events 4 • Adverse events were collected up to 90 days after surgery.
General disorders Weakness	20.0% 3/15 • Number of events 3 • Adverse events were collected up to 90 days after surgery.	11.8% 2/17 • Number of events 2 • Adverse events were collected up to 90 days after surgery.