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FEED-FF for Colorectal Cancer

N/A

Recruiting

Led By Doratha (Armen) Byrd, PhD, MPH

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline, week 6.5 and up to 12.5 weeks

Awards & highlights

Study Summary

"This trial aims to see if a special diet with fermented foods can help rectal cancer patients undergoing treatment and if they find it easy to follow."

Who is the study for?

This trial is for individuals with locally advanced rectal cancer who are about to receive chemoradiotherapy. Participants should be willing to follow a special diet that includes fermented foods and meet other study requirements.Check my eligibility

What is being tested?

The FEED Trial is testing the effects of a high-fermented food diet (FEED-FF) on patients with rectal cancer during their standard chemoradiotherapy treatment, aiming to see if it can improve outcomes.See study design

What are the potential side effects?

Since this trial involves dietary changes rather than medication, side effects may include digestive discomfort or changes in bowel habits due to the introduction of fermented foods.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, week 6.5 and up to 12.5 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, week 6.5 and up to 12.5 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, week 6.5 and up to 12.5 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Effects of FEED-FF diet on local immune-related biomarkers

Effects of FEED-FF diet on quality of life

Effects of FEED-FF diet on the gut microbiome

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: FEED-FFExperimental Treatment1 Intervention

Participants will be asked to pick up the fermented foods at the Research Kitchen at Moffitt. Participants will be asked to eat 3-6 servings of FFs per day, from 1 week prior to treatment start through 12 weeks after treatment start/until the restaging scope is completed. At baseline, the end of week 6.5 and again at week 12.5, participants will be asked to provide biospecimens including a stool sample collected at home and a blood specimen collected in clinic. Participants will be asked to complete a food frequency questionnaire, a quality-of-life survey, two symptom related surveys, and a stool collection questionnaire at these same timepoints. After the dietary intervention, participants will be asked to complete an exit survey to provide feedback on the study and intervention.

Group II: Standard of Care (SUC)Active Control1 Intervention

Participants will receive general healthy eating handouts similar to current usual care documents provided in clinic. These handouts will detail typical healthy foods and the suggested level of intake, or servings per day. At baseline, the end of week 6.5 and again at week 12.5, participants will be asked to provide biospecimens including a stool sample collected at home and a blood specimen collected in clinic. Participants will be asked to complete a food frequency questionnaire, a quality-of-life survey, two symptom related surveys, and a stool collection questionnaire at these same timepoints.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

543 Previous Clinical Trials

135,452 Total Patients Enrolled

Doratha (Armen) Byrd, PhD, MPHPrincipal InvestigatorMoffitt Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals being enlisted for participation in this study?

"Indeed, the details on clinicaltrials.gov indicate that this investigation is presently in search of volunteers. The initial posting date was 2/19/2024 with the latest update noted on 3/22/2024. This study aims to enroll a total of 30 participants at a single designated site."

Answered by AI

Are there any ongoing opportunities for patients to participate in this medical trial?

"Indeed, the details on clinicaltrials.gov affirm that this study is presently seeking suitable candidates. Initially shared on February 19th, 2024, and most recently revised on March 22nd, 2024, the research aims to recruit a total of 30 participants from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial)

2024. "High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06337552.

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