Non-Small Cell Lung Cancer, Rectal Cancer
Conditions
Keywords
Locally Advanced, Rectal Cancer, Non-Small Cell Lung Cancer
Brief 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.
Interventions
OTHERFEED-FF
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.
OTHERStandard 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.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Masking description
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.
Intervention model description
Participants will be randomized to either the FEED-FF Arm or the Standard of Care (SUC) Arm
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for GI Patients: * 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 Inclusion Criteria for Thoracic Patients: * 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effects of the FEED-FF diet on clinical response to chemoradiation (Rectal Cancer Patients) | 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) | 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 | 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 | 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 | 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 | 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 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDoratha (Armen) Byrd, PhD, MPH
Moffitt Cancer Center
Outcome results
None listed