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Dietary Supplement
Nutritional Supplements for Esophageal Cancer
Phase 3
Waitlist Available
Led By Wayne L Hofstetter
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days post-surgery
Awards & highlights
Study Summary
This trial studies a nutritional supplement to see if it reduces complications in patients with esophageal cancer undergoing chemotherapy, radiation therapy, and/or surgery.
Who is the study for?
This trial is for patients with locally advanced esophageal cancer who can undergo chemotherapy, radiation, and/or surgery. They must be able to eat on their own or through a feeding tube but cannot join if they're allergic to the supplement, pregnant, have liver issues, widespread cancer, poor performance status, high creatinine levels in blood or are undergoing salvage resection for squamous cell carcinoma.Check my eligibility
What is being tested?
The study is testing whether Impact Advanced Recovery nutritional drink reduces complications better than standard supplements in patients receiving treatment for esophageal cancer. It aims to see if this special nutrition could help lessen surgical risks and improve overall recovery.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include reactions similar to food allergies due to ingredients in the nutritional supplement. These could range from mild digestive discomfort to more severe allergic responses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days post-surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days post-surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient well-being improvement
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group II (Impact Advanced Recovery)Experimental Treatment1 Intervention
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.
Group II: Group I (standard of care)Active Control1 Intervention
Patients receive standard of care nutritional supplementation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nutritional Supplementation
2019
Completed Early Phase 1
~220
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,781 Total Patients Enrolled
3 Trials studying Esophageal Carcinoma
6,000 Patients Enrolled for Esophageal Carcinoma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,153 Total Patients Enrolled
9 Trials studying Esophageal Carcinoma
7,673 Patients Enrolled for Esophageal Carcinoma
Wayne L HofstetterPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
120 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to the supplement being used in the study.You are able to eat on your own or receive food through a tube in your stomach or intestines.You are unable to eat or receive food through a tube.You have a type of esophageal cancer that can be surgically removed and has not spread to other parts of the body.
Research Study Groups:
This trial has the following groups:- Group 1: Group II (Impact Advanced Recovery)
- Group 2: Group I (standard of care)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are geriatric patients allowed in this trial?
"In order to qualify for this trial, potential patients must be aged 18-80. There are 86 trials for those under 18 and 3446 studies for senior citizens aged 65 and up."
Answered by AI
How can I join forces with other patients in this medical study?
"This prospective clinical trial is seeking 200 patients who have postneoadjuvant therapy stage iiia esophageal squamous cell carcinoma ajcc v8 and are between 18-80 years old."
Answered by AI
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