Status:
WITHDRAWN
Nutritional Supplementation in Reducing Complications in Patients With Locally Advanced Esophageal Cancer Undergoing Chemotherapy, Radiation Therapy, and/or Surgery
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Clinical Stage III Esophageal Adenocarcinoma AJCC v8
Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
PRIMARY OBJECTIVES: I. When compared to the current standard of ad hoc nutritional supplementation on an as-needed basis, scheduled enteral supplementation with Impact Advanced Recovery during the co...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04029857
Start Date
March 14 2019
End Date
January 31 2022
Last Update
February 13 2024
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