Last reviewed · How we verify
Botulinum Toxin Type A in Preventing Complications After Surgery in Patients With Esophageal Cancer
Phase 2 trial testing Botulinum Toxin Type A in Esophageal Carcinoma in 33 participants. Completed in 28 April 2022.
| Lead sponsor | Roswell Park Cancer Institute |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | supportive care |
| Enrollment | 33 |
| Start date | 30 December 2016 |
| Primary completion | 28 January 2022 |
| Estimated completion | 28 April 2022 |
| Sites | 1 location across United States |
Roswell Park Cancer Institute
18 and older, any sex, with Esophageal Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Will be assessed using the intent-to-treat principle and a one-sided Cochran-Mantel-Haenszel (CMH) test.
| Group | Value | 95% CI |
|---|---|---|
| Arm I (Botulinum Toxin Type A, Esophagectomy) | 12 | |
| Arm II (Esophagectomy) | 14 | |
| Arm I (Botulinum Toxin Type A, Esophagectomy) | 1 | |
| Arm II (Esophagectomy) | 3 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Arm I (Botulinum Toxin Type A, Esophagectomy) | 12 | |
| Arm II (Esophagectomy) | 14 | |
| Arm I (Botulinum Toxin Type A, Esophagectomy) | 1 | |
| Arm II (Esophagectomy) | 3 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Arm I (Botulinum Toxin Type A, Esophagectomy) | 22.6 | ± 4.7 |
| Arm II (Esophagectomy) | 27 | ± 16.2 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Arm I (Botulinum Toxin Type A, Esophagectomy) | 7.9 | ± 4.2 |
| Arm II (Esophagectomy) | 8.1 | ± 1.9 |
The rate of secondary procedures (within 90 days) will be compared between treatment arms using a one-sided CMH exact test.
| Group | Value | 95% CI |
|---|---|---|
| Arm I (Botulinum Toxin Type A, Esophagectomy) | 1 | |
| Arm II (Esophagectomy) | 0 | |
| Arm I (Botulinum Toxin Type A, Esophagectomy) | 10 | |
| Arm II (Esophagectomy) | 15 |
The rate of post-operative pulmonary events will be compared between treatment arms using the two-sided CMH exact test.
| Group | Value | 95% CI |
|---|---|---|
| Arm I (Botulinum Toxin Type A, Esophagectomy) | 3 | |
| Arm II (Esophagectomy) | 3 | |
| Arm I (Botulinum Toxin Type A, Esophagectomy) | 9 | |
| Arm II (Esophagectomy) | 13 |
Time frame: Adverse events were collected up to 90 days after surgery.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Arm I (Botulinum Toxin Typ… | Arm II (Esophagectomy) |
|---|---|---|---|
| Vomiting | Gastrointestinal disorders | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
| Postoperative thoracic procedure complication | Surgical and medical procedures | — | — |
| Reaction | System | Arm I (Botulinum Toxin Typ… | Arm II (Esophagectomy) |
|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | — | — |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — |
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Weakness | General disorders | — | — |
| Aspiration | Respiratory, thoracic and mediastinal disorders | — | — |
| Bloating | Gastrointestinal disorders | — | — |
| Chest pain | Cardiac disorders | — | — |
| Hypotension | Cardiac disorders | — | — |
| Urinary retention | Renal and urinary disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
Most-reported serious reactions: Vomiting, Atrial fibrillation, Postoperative thoracic procedure complication.
Data from ClinicalTrials.gov NCT02965976 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02965976.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing