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NEAAR Medical Food for Rectal Cancer (NEAAR-LARC Trial)
N/A
Recruiting
Led By Richard R Tuli, MD
Research Sponsored by University of South Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No evidence of distant metastasis
Histologically confirmed diagnosis of adenocarcinoma of the rectum
Must not have
Insulin-dependent diabetes
Body mass index (BMI) <18.5 kg/m2 or >40 kg/m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether a special diet supplement is safe and well-tolerated for adult patients with advanced rectal cancer who are undergoing radiation therapy and chemotherapy.
Who is the study for?
This trial is for adults with locally advanced rectal cancer. Participants should be able to follow a special diet (NEAAR Medical Food) during standard radiotherapy and chemotherapy treatments.
What is being tested?
The study tests the NEAAR Medical Food's effects on patients undergoing typical treatment for rectal cancer, including its feasibility, safety, how well people can stick to it, and if it causes any discomfort.
What are the potential side effects?
Potential side effects are not specified but may include digestive changes due to dietary restrictions. The focus is on tolerability and compliance with the NEAAR diet alongside conventional therapies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has not spread to distant parts of my body.
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My diagnosis is rectal adenocarcinoma.
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My cancer is at stage II or III according to MRI results.
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I have never received chemotherapy.
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I am 18 years old or older.
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I am a candidate for surgery to remove rectal cancer.
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I have not had radiation therapy to my pelvic area.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I use insulin for my diabetes.
Select...
My BMI is either below 18.5 or above 40.
Select...
I am experiencing severe weight loss or lack of appetite that is not responding to treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Nonessential Amino Acid Restriction (NEAAR) Medical FoodExperimental Treatment1 Intervention
This is a single arm study in which all subjects will receive NEAAR medical food.
Find a Location
Who is running the clinical trial?
University of South FloridaLead Sponsor
427 Previous Clinical Trials
192,601 Total Patients Enrolled
Richard R Tuli, MDPrincipal InvestigatorUniversity of South Florida