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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FEED-FF | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | At Baseline, Week 6.5 and Up to 12.5 Weeks |
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Inclusion Criteria for GI Patients:
Inclusion Criteria for Thoracic Patients:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Doratha (Armen) Byrd, PhD, MPH | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
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| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials Website | View source |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Participants will be randomized to either the FEED-FF Arm or the Standard of Care (SUC) Arm
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Clinical response will be determined in clinic when patients undergo blinded tumor assessments by standard digital rectal exam, endoscopy, and rectal MRI at baseline and at the end of the intervention.
| 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. |
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| 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. | 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. | At Baseline, Week 6.5 and Up to 12.5 Weeks |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |