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New treatment option for Rectal Cancer
Official title Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)
ClinicalTrials.gov ID: NCT06380101
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- 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
You likely can't join if
- Patients unable to undergo MRI
- Other anticancer or experimental therapy
- Body mass index (BMI) \ 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...
See the full eligibility 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
- Patients unable to undergo MRI
- Other anticancer or experimental therapy
- Body mass index (BMI) \ 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...
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.