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

ConditionRectal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of South Florida

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • NEAAR Medical Food

    Other intervention

    Standardized non-essential amino acid restricted medical food.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Nonessential Amino Acid Restriction (NEAAR) Medical FoodExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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 outcomes

1

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
2

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
3

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
4

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.

Other outcomes

Sponsors and contacts

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University of South Florida

Lead sponsor

Source ClinicalTrials.gov
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