Non-Small Cell Lung Cancer (NSCLC) Clinical Trials

Find Non-Small Cell Lung Cancer (NSCLC) Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of the study is to evaluate the feasibility and acceptability of a dietary intervention (FEED-FF) that includes fermented foods (FF), among locally advanced rectal cancer patients and non-small cell lung cancer (NSCLC) patients, and to explore whether this diet can improve outcomes in rectal cancer patients receiving chemoradiation and NSCLC patients receiving immunotherapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years of age or older

• Diagnosed with locally advanced rectal cancer (Stage II-III)

• Will undergo neoadjuvant chemoradiation at Moffitt Cancer Center

• Able to pick up FFs once/weekly at Moffitt

• Able to speak and read English

• Able to consume foods orally

• Able to provide informed consent

• 18 years of age or older

• Diagnosed with stage II-IV non-small cell lung cancer (NSCLC)

• Will undergo Immunotherapy with immune checkpoint inhibitors (+/- chemotherapy or other treatment) at Moffitt Cancer Center

• Able to pick up FFs once/weekly at Moffitt

• Able to speak and read English

• Able to consume foods orally

• Able to provide informed consent

Locations
United States
Florida
Moffitt Cancer Center
RECRUITING
Tampa
Contact Information
Primary
Stephanie Hogue
Stephanie.Hogue@moffitt.org
813-745-1891
Time Frame
Start Date: 2024-04-04
Estimated Completion Date: 2027-03
Participants
Target number of participants: 54
Treatments
Experimental: FEED-FF
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.
Active_comparator: Standard of Care (SUC)
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.
Sponsors
Leads: H. Lee Moffitt Cancer Center and Research Institute

This content was sourced from clinicaltrials.gov