Clinical trial · Interventional
Nutritional Supplementation in Reducing Complications in Patients With Locally Advanced Esophageal Cancer Undergoing Chemotherapy, Radiation Therapy, and/or Surgery
Nutritional Supplementation for Esophageal Cancer Patients Undergoing Trimodality Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 0 participant accrual
Summary
Brief summary (as posted)
This phase III trial studies nutritional supplementation with Impact Advanced Recovery to see how well it works compared with standard nutritional supplementation in reducing complications in patients with esophageal cancer that has spread to nearby tissue or lymph nodes (locally advanced) who are undergoing chemotherapy, radiation therapy, and/or surgery. Impact Advanced Recovery may help to reduce the number of surgical complications, reduce toxicity, improve nutritional status before surgery, and reduce morbidity after surgery in patients with esophageal cancer.
Conditions
Conditions (15)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clinical Stage III Esophageal Adenocarcinoma AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8 | — | UNRESOLVED | — |
| Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8 | — | UNRESOLVED | — |
| Pathologic Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8 | — | UNRESOLVED | — |
| Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8 | — | UNRESOLVED | — |
| Pathologic Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8 | — | UNRESOLVED | — |
| Pathologic Stage III Esophageal Adenocarcinoma AJCC v8 | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nutritional Supplementation | Dietary Supplement | — | UNRESOLVED |
| Nutritional Supplement Drink | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group I (standard of care)
- description
- Patients receive standard of care nutritional supplementation.
- interventionNames
- Dietary Supplement: Nutritional Supplement Drink
- type
- EXPERIMENTAL
- label
- Group II (Impact Advanced Recovery)
- description
- Patients receive Impact Advanced Recovery PO or via feeding tube BID on days 1-7 for weeks 1, 3, and 5 during chemotherapy and radiation therapy before surgery. Starting 5-7 days before surgery, patients receive Impact Advanced Recovery PO TID until surgery. Within 2 days following surgery, patients may continue to receive Impact Advanced Recovery via feeding tube at the discretion of the treating physician.
- interventionNames
- Dietary Supplement: Nutritional Supplementation
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Resectable, locally advanced esophageal cancer (adenocarcinoma, squamous cell, other histology). * Medically operable. * Treatment plan for (i) chemoradiation then surgery or chemotherapy followed by chemoradiation then surgery, or (ii) salvage esophagectomy. * Able to tolerate feeds either orally or via tube gastrostomy or enterostomy. Exclusion Criteria: * Allergy to supplement. * Pregnant. * Hepatic insufficiency. * Serum creatinine \> 2.0. * Metastatic disease. * Performance status of \> or equal to 2. * Inability to take either oral intake or enteral feeds or both. * Given increased rates of perioperative morbidity and mortality historically observed at our institution, patients undergoing salvage resection for squamous cell carcinoma will not be eligible for enrollment.
References
Publications (0)
Data not yet available