Pancreatic Ductal Adenocarcinoma
Conditions
Keywords
pancreatic adenocarcinoma, broccoli sprouts, sulforaphane, palliative chemotherapy, cancer stem cells
Brief summary
The goal of the POUDER trial is to determine the feasibility of a randomized controlled trial regarding the application of freeze-dried broccoli sprouts rich in sulforaphane and quercetin in patients with advanced pancreatic ductal adenocarcinoma that receive palliative chemotherapy.
Detailed description
Patients will be randomly classified into two groups - verum and placebo. The patients in the experimental arm will receive capsules with broccoli sprout grain containing a total of 90mg sulforaphane active substance per day over one year as nutrition supplement whereas patients assigned to the placebo group will receive inactive substance (methylcellulose) with identical capsule and portion distribution.
Interventions
DIETARY_SUPPLEMENTVerum, broccoli sprout grain
Patients will be randomly classified into two groups - verum and placebo. The patients in the experimental arm will receive capsules with broccoli sprout grain containing a total of 90mg sulforaphane active substance per day over one year as nutrition supplement whereas patients assigned to the placebo group will receive inactive substance (methylcellulose) with identical capsule and portion distribution.
DIETARY_SUPPLEMENTplacebo
Patients assigned to the placebo group will receive inactive substance (methylcellulose) with identical capsule and portion distribution as the experimental arm.
Sponsors
German Cancer Research Center
Heidelberg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Advanced, surgically non-treatable pancreatic ductal adenocarcinoma (surgical exploration, intraoperative biopsy but also palliative bypass interventions (bileodigestive anastomosis and/or gastroenterostomy because of preoperative cholestasis or impaired gastric emptying due to tumor-mass effect) * Intact gastric emptying * Written informed consent * Patients ≥18 years of age * Palliative chemotherapy
Exclusion criteria
* Intolerance to broccoli or its ingredients * Impaired mental status or language problems / barriers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of a randomized controlled trial | One year | Main objective is to test the feasibility of a randomized controlled trial regarding the application of freeze-dried broccoli sprouts rich in sulforaphane and quercetin in patients with advanced, surgically non-resectable pancreatic ductal adenocarcinoma treated with palliative chemotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease status (imaging and tumor markers) | One year | Disease status (cancer progress or regress): CT-imaging staging (if available) and serum tumor markers (CEA and CA-19-9) peaks as additional parameters that provide insight into disease status. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Substance bioavailability | One year | Urine analysis as marker of substance systemic bioavailability (conversion of the precursor glucoraphanin to the active drug substance sulforaphane). Urine analysis serves as control of the regular intake of the test substance as well. |
Countries
Germany
Contacts
Primary ContactPeter Schemmer, Prof. Dr. med.
Backup ContactVladimir J. Lozanovski, M.D.
Outcome results
None listed