Rectal CancerNCT06337552
High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial)
A study testing FEED-FF in people with Rectal Cancer and Non-Small Cell Lung Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Non-Small Cell Lung Cancer
- What is being tested?
- FEED-FF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2024to Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- Antibiotic use within 1 month prior to baseline
- If currently using probiotics, unwillingness to cease probiotic use
- Previous receipt of surgery, immunotherapy, chemotherapy, or radiation for a colon or rectal tumor
- Per clinician's discretion, clinician confirmed inflammatory bowel conditions (e.g., ulcerative colitis, Crohn's disease)
- Infectious disease diagnosed <1 month prior to baseline
- Already consuming ≥2 servings of fermented foods/day
- Previously diagnosed with a mast cell disorder or histamine allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial)
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.
- Conditions
- Rectal Cancer, Non-Small Cell Lung Cancer
- Being tested
- FEED-FF, Standard of Care (SUC)
- Keywords
- Locally Advanced, Rectal Cancer, Non-Small Cell Lung Cancer
- Medical subject headings
- Rectal Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FEED-FFOther
3-6 servings of any combination of the following fermented foods/day (from 1 week prior to treatment to approximately 12 weeks after the start of treatment): Yogurt, cottage cheese, kefir, kombucha, sauerkraut, and kimchi.
Standard of Care (SUC)Other
Standard of Care (SUC) is the treatment that is accepted by medical experts as a proper treatment for a certain type of disease and that is widely used by health care professionals. Standard of Care will comprise general healthy eating handouts that describe typical healthy foods and the suggested level of servings per day.
| Study group | Role | What they receive |
|---|---|---|
| FEED-FF | Experimental | 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. Receives: Other: FEED-FF |
| Standard of Care (SUC) | Active comparator | 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. Receives: Other: Standard of Care (SUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of the FEED-FF diet on clinical response to chemoradiation (Rectal Cancer Patients)
Clinical response measured in clinic by MRI/Endoscopy/Digital rectal exam, comparing the FEED-FF arm to SUC arm.
Indicators of clinical response are Complete Response, Near Complete Response, Incomplete Response, or Progressive Disease.
Measured: At Baseline and Up to 12.5 Weeks
Effects of the FEED-FF diet on clinical response to immunotherapy (Lung Cancer Patients)
Clinical benefit to immune checkpoint inhibitor therapy will be measured in clinic by MRI/Endoscopy, comparing the FEED-FF arm to SUC arm.
Defined as the best response of complete tumor resolution (CR), Partial Response (PR), and stable tumor size (SD) within 12 months.
Progressive Disease (PD) within 12 months indicates no clinical benefit.
Measured: At Baseline and Up to 12.5 Weeks
Effects of FEED-FF diet on the gut microbiome
Measured by fecal biospecimen sample collection; FEED-FF arm hypothesized to demonstrate increases in short chain fatty acid (SCFA) producing bacteria and higher alpha diversity compared to SUC arm.
Measured: At Baseline, Week 6.5 and Up to 12.5 Weeks
Effects of FEED-FF diet on local immune-related biomarkers
Measured by FFPE tissue slides; FEED-FF arm hypothesized to demonstrate enhanced immune response such as higher T-cell expression compared to SUC arm.
Measured: At Baseline and Up to 12.5 Weeks
Effects of FEED-FF diet on quality of life
Measured by using the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Survey; FEED-FF arm hypothesized to demonstrate more favorable QoL compared to SUC arm.
Measured: At Baseline, Week 6.5 and Up to 12.5 Weeks
Efficacy of the FEED-FF intervention
Measured by an accrual rate of 50% of eligible patients, fermented foods (FF) intake of at least 3 servings on at least 80% of days, and at least 80% of intervention group reporting high/very high satisfaction with intervention.
Weekly goal adherence via randomly administered food logs, tracking responses to and general completion of an exit survey will be utilized.
Measured: At Baseline, Week 6.5 and Up to 12.5 Weeks
Feasibility of the FEED-FF intervention
Measured by an accrual rate of 50% of eligible patients, fermented foods (FF) intake of at least 3 servings on at least 80% of days, and at least 80% of intervention group reporting high/very high satisfaction with intervention.
Weekly goal adherence via randomly administered food logs, tracking responses to and general completion of an exit survey will be utilized.
Measured: At Baseline, Week 6.5 and Up to 12.5 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start4 Apr 2024
- Primary completion2 Jul 2026
- Study completionJan 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 H. Lee Moffitt Cancer Center and Research InstituteThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either the FEED-FF Arm or the Standard of Care (SUC) Arm
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Doratha (Armen) Byrd, PhD, MPH, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337552
- Sponsor's protocol ID
- MCC-22709
- Status last verified
- Sep 2026
- First submitted
- 18 Mar 2024
- Last updated
- 23 Sep 2026
- 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial)
- ClinicalTrials.gov ID
- NCT06337552
- Acronym / sponsor ID
- MCC-22709
- Conditions
- Rectal Cancer, Non-Small Cell Lung Cancer
- Keywords
- Locally Advanced, Rectal Cancer, Non-Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 39 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 2 Jul 2026 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 29 Mar 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Participants will be randomized to either the FEED-FF Arm or the Standard of Care (SUC) Arm
| Arm | Type | Receives |
|---|---|---|
| FEED-FF | Experimental | Other: FEED-FFParticipants 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. |
| Standard of Care (SUC) | Active comparator | Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (7 listed)
- Antibiotic use within 1 month prior to baseline
- If currently using probiotics, unwillingness to cease probiotic use
- Previous receipt of surgery, immunotherapy, chemotherapy, or radiation for a colon or rectal tumor
- Per clinician's discretion, clinician confirmed inflammatory bowel conditions (e.g., ulcerative colitis, Crohn's disease)
- Infectious disease diagnosed <1 month prior to baseline
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 |
|---|---|---|
| FEED-FF3-6 servings of any combination of the following fermented foods/day (from 1 week prior to treatment to approximately 12 weeks after the start of treatment): Yogurt, cottage cheese, kefir, kombucha, sauerkraut, and kimchi. | Other | FEED-FF |
| Standard of Care (SUC)Standard of Care (SUC) is the treatment that is accepted by medical experts as a proper treatment for a certain type of disease and that is widely used by health care professionals. Standard of Care will comprise general healthy eating handouts that describe typical healthy foods and the suggested level of servings per day. | Other | Standard of Care (SUC) |
Primary outcome
Effects of the FEED-FF diet on clinical response to chemoradiation (Rectal Cancer Patients)
Time frame: At Baseline and Up to 12.5 Weeks
Clinical response measured in clinic by MRI/Endoscopy/Digital rectal exam, comparing the FEED-FF arm to SUC arm. Indicators of clinical response are Complete Response, Near Complete Response, Incomplete Response, or Progressive Disease.
Effects of the FEED-FF diet on clinical response to immunotherapy (Lung Cancer Patients)
Time frame: At Baseline and Up to 12.5 Weeks
Clinical benefit to immune checkpoint inhibitor therapy will be measured in clinic by MRI/Endoscopy, comparing the FEED-FF arm to SUC arm. Defined as the best response of complete tumor resolution (CR), Partial Response (PR), and stable tumor size (SD) within 12 months. Progressive Disease (PD) within 12 months indicates no clinical benefit.
Effects of FEED-FF diet on the gut microbiome
Time frame: At Baseline, Week 6.5 and Up to 12.5 Weeks
Measured by fecal biospecimen sample collection; FEED-FF arm hypothesized to demonstrate increases in short chain fatty acid (SCFA) producing bacteria and higher alpha diversity compared to SUC arm.
Effects of FEED-FF diet on local immune-related biomarkers
Time frame: At Baseline and Up to 12.5 Weeks
Measured by FFPE tissue slides; FEED-FF arm hypothesized to demonstrate enhanced immune response such as higher T-cell expression compared to SUC arm.
Effects of FEED-FF diet on quality of life
Time frame: At Baseline, Week 6.5 and Up to 12.5 Weeks
Measured by using the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Survey; FEED-FF arm hypothesized to demonstrate more favorable QoL compared to SUC arm.
Efficacy of the FEED-FF intervention
Time frame: At Baseline, Week 6.5 and Up to 12.5 Weeks
Measured by an accrual rate of 50% of eligible patients, fermented foods (FF) intake of at least 3 servings on at least 80% of days, and at least 80% of intervention group reporting high/very high satisfaction with intervention. Weekly goal adherence via randomly administered food logs, tracking responses to and general completion of an exit survey will be utilized.
Feasibility of the FEED-FF intervention
Time frame: At Baseline, Week 6.5 and Up to 12.5 Weeks
Measured by an accrual rate of 50% of eligible patients, fermented foods (FF) intake of at least 3 servings on at least 80% of days, and at least 80% of intervention group reporting high/very high satisfaction with intervention. Weekly goal adherence via randomly administered food logs, tracking responses to and general completion of an exit survey will be utilized.
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 23 Sep 2026.
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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. This study is not recruiting at the moment.
Doratha (Armen) Byrd, PhD, MPH principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FEED-FF in people with Rectal Cancer and Non-Small Cell Lung Cancer, run by H. Lee Moffitt Cancer Center and Research Institute 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 14 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of the FEED-FF diet on clinical response to chemoradiation (Rectal Cancer Patients) (time frame: At Baseline and Up to 12.5 Weeks). The study lists 7 primary outcomes in all. 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 23 Sep 2026.