Rectal CancerNEAAR-LARCNCT06380101
Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)
A study testing NEAAR Medical Food in people with Rectal Cancer, run by University of South Florida at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- NEAAR Medical Food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2023to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of South Florida
Tampa, Florida, 33606
Jennifer Burgess, MS, 434-806-6445, jburgess@tgh.org
Veronique Perry, MSHA, 2549873658, vperry@tgh.org
About this study
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
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.
- Conditions
- Rectal Cancer
- Being tested
- NEAAR Medical Food
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEAAR Medical FoodOther
Standardized non-essential amino acid restricted medical food.
| Study group | Role | What they receive |
|---|---|---|
| Nonessential Amino Acid Restriction (NEAAR) Medical Food | Experimental | This is a single arm study in which all subjects will receive NEAAR medical food. Receives: Other: NEAAR Medical Food |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of CTCAE v5.0 non-hematological Grade 3 and higher diarrhea
Measured: During standard of care Short-course radiotherapy and total neoadjuvant therapy, up to approximately 1 year
Secondary outcomes (4)
Proportion of clinical complete response 8 weeks post SCRT-TNT with NEAAR medical food defined by the MSK Regression Schema
Measured: approximately 8 weeks after SCRT-TNT with NEAAR medical food intervention
Absolute and relative change from baseline of circulating non-essential amino acids
Measured: 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
Measured: approximately 4 weeks after SCRT with NEAAR medical food intervention
molecular ctDNA response.
Measured: approximately 4 weeks after SCRT with NEAAR medical food intervention and 8 weeks post SCRT-TNT with NEAAR medical food intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start8 Sep 2023
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard R Tuli, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380101
- Sponsor's protocol ID
- NEAAR-LARC
- Acronym
- NEAAR-LARC
- Status last verified
- Dec 2025
- First submitted
- 18 Apr 2024
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06380101
- Acronym / sponsor ID
- NEAAR-LARC / NEAAR-LARC
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 23 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nonessential Amino Acid Restriction (NEAAR) Medical Food | Experimental | Other: NEAAR Medical FoodThis is a single arm study in which all subjects will receive NEAAR medical food. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEAAR Medical FoodStandardized non-essential amino acid restricted medical food. | Other | Nonessential Amino Acid Restriction (NEAAR) Medical Food |
Primary outcome
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
4 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
Related trials for Rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard R Tuli, MD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEAAR Medical Food in people with Rectal Cancer, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Richard R Tuli, MD (813 844 7585, rtuli@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.