Exploring how diet and gut bacteria affect chemotherapy response in pancreatic cancer
Determining the Link Between Dietary Patterns, Fecal Microbiome and Response to Neoadjuvant Chemotherapy in Pancreatic Ductal Adenocarcinoma Patients
This study is testing how diet and gut bacteria affect how well people with pancreatic cancer respond to chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 87 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT06595160 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between dietary patterns and the gut microbiome in patients with pancreatic ductal adenocarcinoma undergoing neoadjuvant chemotherapy. It aims to evaluate how the diversity of the fecal microbiome and the Healthy Eating Index (HEI-2015) dietary score correlate with the patients' response to treatment. Participants will complete a dietary survey and provide fecal samples for analysis. The findings could help tailor dietary recommendations to improve treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a histological diagnosis of resectable or borderline resectable pancreatic ductal adenocarcinoma.
Not a fit: Patients with locally advanced or metastatic stage IV pancreatic cancer or those who have previously received neoadjuvant chemotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized dietary interventions that enhance the effectiveness of chemotherapy in pancreatic cancer patients.
How similar studies have performed: While the relationship between diet, microbiome, and cancer treatment is being explored, this specific approach is relatively novel and has not been extensively tested in pancreatic cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \* Age ≥ 18 years with signed informed consent form * Patients must have a histological diagnosis of PDAC * Resectable or borderline resectable PDAC on imaging Exclusion Criteria: * \* Patients with locally advanced and metastatic stage IV PDAC * Patients who have already received or completed neoadjuvant chemotherapy for PDAC * Patients with active malignancy receiving systemic therapy
Where this trial is running
Atlanta, Georgia
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Mihir M Shah — Emory University Hospital/Winship Cancer Institute
- Study coordinator: Mihir M. Shah, MD, FACS, FSSO
- Email: mihir.m.shah@emory.edu
- Phone: 404-778-3307
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.