Nutritional Supplementation in Reducing Complications in Patients With Locally Advanced Esophagea… (NCT04029857) | Clinical Trial Compass
WithdrawnPhase 3
Nutritional Supplementation in Reducing Complications in Patients With Locally Advanced Esophageal Cancer Undergoing Chemotherapy, Radiation Therapy, and/or Surgery
Stopped: 0 participant accrual
0Started 2019-03-14
Plain-language 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 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.