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Nonessential Amino Acid Restriction (NEAAR) Medical Food for Colorectal 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during standard of care short-course radiotherapy and total neoadjuvant therapy, up to approximately 1 year

Awards & highlights

NEAAR-LARC Trial 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.Check my eligibility

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.See study design

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.

NEAAR-LARC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

NEAAR-LARC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during standard of care short-course radiotherapy and total neoadjuvant therapy, up to approximately 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during standard of care short-course radiotherapy and total neoadjuvant therapy, up to approximately 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and during standard of care short-course radiotherapy and total neoadjuvant therapy, up to approximately 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of CTCAE v5.0 non-hematological Grade 3 and higher diarrhea

Secondary outcome measures

Absolute and relative change from baseline of circulating non-essential amino acids

Proportion of clinical complete response 8 weeks post SCRT-TNT with NEAAR medical food defined by the MSK Regression Schema

Proportion of clinical complete response at Week 4 post SCRT with NEAAR medical food

+1 more

NEAAR-LARC 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.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of South FloridaLead Sponsor

413 Previous Clinical Trials

188,237 Total Patients Enrolled

Richard R Tuli, MDPrincipal InvestigatorUniversity of South Florida

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants undergoing examination in this clinical trial?

"Indeed, the information on clinicaltrials.gov states that this medical investigation is actively seeking suitable candidates. The trial was initially published on September 8th, 2023 and last revised on April 18th, 2024. To complete the study successfully, they aim to recruit around 30 participants from a single site."

Answered by AI

Does this medical study accept participants who have reached the age of 18 and above?

"This research study is open to individuals over 18 years old and below a century in age."

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Which individuals meet the eligibility criteria to participate in this clinical study?

"Eligible participants for this research need to have been diagnosed with colorectal cancer and fall within the age range of 18 to 100 years. The trial is accepting approximately 30 patients in total."

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Are patients currently able to participate in this ongoing trial?

"As documented on clinicaltrials.gov, this research endeavor is presently in search of eligible participants. The trial was initially shared on September 8th, 2023, with the most recent update made on April 18th, 2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)

2023. "Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06380101.

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