A Randomized High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Effects of the FEED-FF diet on clinical response to chemoradiation (Rectal Cancer Patients)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: FEED-FF (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.
干预措施: Standard of Care (SUC) (Other)
结局指标
主要结局
Effects of the FEED-FF diet on clinical response to chemoradiation (Rectal Cancer Patients)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点