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2013-12
2015-12
2015-12
40
NCT01879878
Heidelberg University
Heidelberg University
INTERVENTIONAL
Pilot Study Evaluating Broccoli Sprouts in Advanced Pancreatic Cancer [POUDER Trial]
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2013-06-13 | N/A | 2015-05-27 |
2013-06-17 | N/A | 2015-05-28 |
2013-06-18 | N/A | 2015-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Triple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Verum, broccoli sprout grain Active sulforaphane distributed in capsules each containing broccoli sprout grain | DIETARY_SUPPLEMENT: Verum, broccoli sprout grain
|
| PLACEBO_COMPARATOR: Placebo Inactive substances (methylcellulose) with identical capsule and portion distribution | DIETARY_SUPPLEMENT: placebo
|
| Primary Outcome Measures | 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 |
| Secondary Outcome Measures | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Peter Schemmer, Prof. Dr. med. Phone Number: +49 6221 566205 Email: peter.schemmer@med.uni-heidelberg.de |
Study Contact Backup Name: Vladimir J. Lozanovski, M.D. Phone Number: +49 6221 5636439 Email: vladimir.lozanovski@med.uni-heidelberg.de |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
