Pilot Study Evaluating Broccoli Sprouts in Advanced Pancreatic Cancer [POUDER Trial] (POUDER)
|ClinicalTrials.gov Identifier: NCT01879878|
Recruitment Status : Unknown
Verified May 2015 by Peter Schemmer, Heidelberg University.
Recruitment status was: Recruiting
First Posted : June 18, 2013
Last Update Posted : May 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Ductal Adenocarcinoma||Dietary Supplement: Verum, broccoli sprout grain Dietary Supplement: placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Pilot Study Evaluating Broccoli Sprouts in Advanced Pancreatic Cancer [POUDER Trial]|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
Experimental: Verum, broccoli sprout grain
Active sulforaphane distributed in capsules each containing broccoli sprout grain
Dietary Supplement: Verum, 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.
Other Name: glucoraphanin
Placebo Comparator: Placebo
Inactive substances (methylcellulose) with identical capsule and portion distribution
Dietary Supplement: placebo
Patients assigned to the placebo group will receive inactive substance (methylcellulose) with identical capsule and portion distribution as the experimental arm.
- Feasibility of a randomized controlled trial [ Time Frame: 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
- Disease status (imaging and tumor markers) [ Time Frame: 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.
- Substance bioavailability [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01879878
|Contact: Peter Schemmer, Prof. Dr. med.||+49 6221 email@example.com|
|Contact: Vladimir J. Lozanovski, M.D.||+49 6221 firstname.lastname@example.org|
|Dept. of General and Transplant Surgery, University Hospital of Heidelberg, Germany||Recruiting|
|Heidelberg, Germany, 69120|
|Contact: Vladimir J. Lozanovski, M.D. +49 6221 5636439 email@example.com|
|Sub-Investigator: Vladimir J. Lozanovski, M.D.|
|Study Director:||Peter Schemmer, Prof. Dr. med.||Heidelberg University|
|Principal Investigator:||Ingrid Herr, Prof. Dr.||Heidelberg University|