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

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of South Florida
Study ID
NCT06380101
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 8, 2023
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Nonessential Amino Acid Restriction (NEAAR) Medical Food
    This is a single arm study in which all subjects will receive NEAAR medical food.

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of South FloridaTampaFlorida33606
Jennifer Burgess, MS
[email protected]
434-806-6445
Veronique Perry, MSHA
[email protected]
2549873658
Richard Tuli, MD (PRINCIPAL_INVESTIGATOR)

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