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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1144-2013 | Other Identifier | WHO |
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| Name | Class |
|---|---|
| German Cancer Research Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum, broccoli sprout grain | Experimental | Active sulforaphane distributed in capsules each containing broccoli sprout grain |
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| Placebo | Placebo Comparator | Inactive substances (methylcellulose) with identical capsule and portion distribution |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verum, broccoli sprout grain | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of a randomized controlled trial | 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 | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Disease status (imaging and tumor markers) | 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. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Substance bioavailability | 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. | One year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Schemmer, Prof. Dr. med. | Contact | +49 6221 566205 | peter.schemmer@med.uni-heidelberg.de | |
| Vladimir J. Lozanovski, M.D. | Contact | +49 6221 5636439 | vladimir.lozanovski@med.uni-heidelberg.de |
| Name | Affiliation | Role |
|---|---|---|
| Peter Schemmer, Prof. Dr. med. | Heidelberg University | Study Director |
| Ingrid Herr, Prof. Dr. | Heidelberg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of General and Transplant Surgery, University Hospital of Heidelberg, Germany | Recruiting | Heidelberg | 69120 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24894410 | Derived | Lozanovski VJ, Houben P, Hinz U, Hackert T, Herr I, Schemmer P. Pilot study evaluating broccoli sprouts in advanced pancreatic cancer (POUDER trial) - study protocol for a randomized controlled trial. Trials. 2014 Jun 3;15:204. doi: 10.1186/1745-6215-15-204. |
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| ID | Term |
|---|---|
| C119494 | glucoraphanin |
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| placebo | Dietary Supplement | Patients assigned to the placebo group will receive inactive substance (methylcellulose) with identical capsule and portion distribution as the experimental arm. |
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