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Recruiting NCT06380101

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

No phase Interventional Rectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NEAAR Medical Food.
Who it may be relevant to
Registry conditions: Rectal Cancer. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Prospective, Single Arm IIA Study to Evaluate the Feasibility of a Standardized Nonessential Amino Acid Restriction (NEAAR) Medical Food in Combination With Total Neoadjuvant Therapy (TNT) for Management of Locally Advanced Rectal Cancer (LARC) NEAAR-LARC

Overview

This clinical study aims to assess feasibility, safety, tolerability, and compliance of a Nonessential Amino Acid Restriction (NEAAR) medical food in adult patients with locally advanced rectal cancer during standard of care short course radiotherapy followed by standard of care chemotherapy.

Interventions

  • Other NEAAR Medical Food
    Standardized non-essential amino acid restricted medical food.

Primary outcome measures

  • Rate of CTCAE v5.0 non-hematological Grade 3 and higher diarrhea [Time frame: During standard of care Short-course radiotherapy and total neoadjuvant therapy, up to approximately 1 year]
Secondary outcome measures (4)
  • Proportion of clinical complete response 8 weeks post SCRT-TNT with NEAAR medical food defined by the MSK Regression Schema [Time frame: approximately 8 weeks after SCRT-TNT with NEAAR medical food intervention]
  • Absolute and relative change from baseline of circulating non-essential amino acids [Time frame: from baseline up to approximately 8 weeks after SCRT-TNT with NEAAR medical food intervention]
  • Proportion of clinical complete response at Week 4 post SCRT with NEAAR medical food [Time frame: approximately 4 weeks after SCRT with NEAAR medical food intervention]
  • molecular ctDNA response. [Time frame: approximately 4 weeks after SCRT with NEAAR medical food intervention and 8 weeks post SCRT-TNT with NEAAR medical food intervention.]

Eligibility criteria

Inclusion criteria

  • Histologically confirmed diagnosis of adenocarcinoma of the rectum
  • Clinical stage II (cT3-4, N-) or Stage III (cT any, N+) based on MRI
  • Eligible for total mesorectal excision
  • No evidence of distant metastasis
  • No prior pelvic radiation therapy
  • No prior chemotherapy
  • Age ≥18 years

Exclusion criteria

  • Patients unable to undergo MRI
  • Other anticancer or experimental therapy
  • Body mass index (BMI) <18.5 kg/m2 or >40 kg/m2
  • Serious or refractive cachexia or anorexia
  • Insulin-dependent diabetes Taking or needs to take any protein or amino acid containing nutritional supplements (e.g., Ensure®) Patients with a condition where high-fat or fatty food is contraindicated History of confirmed food allergy Active wound or skin graft that would require a significant increase in protein requirements for skin integrity and healing

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • University of South Florida — Tampa

Identifiers

NCT: NCT06380101 · NEAAR-LARC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗