- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01879878
Pilot Study Evaluating Broccoli Sprouts in Advanced Pancreatic Cancer [POUDER Trial] (POUDER)
May 27, 2015 updated by: Peter Schemmer, Heidelberg University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
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
Study Locations
-
-
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Heidelberg, Germany, 69120
- Recruiting
- Dept. of General and Transplant Surgery, University Hospital of Heidelberg, Germany
-
Contact:
- Vladimir J. Lozanovski, M.D.
- Phone Number: +49 6221 5636439
- Email: vladimir.lozanovski@med.uni-heidelberg.de
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Sub-Investigator:
- Vladimir J. Lozanovski, M.D.
-
-
Participation Criteria
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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- 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
|
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 Names:
|
PLACEBO_COMPARATOR: Placebo
Inactive substances (methylcellulose) with identical capsule and portion distribution
|
Patients assigned to the placebo group will receive inactive substance (methylcellulose) with identical capsule and portion distribution as the experimental arm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
One year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Peter Schemmer, Prof. Dr. med., Heidelberg University
- Principal Investigator: Ingrid Herr, Prof. Dr., Heidelberg University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
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 Major Dates
Study Start
December 1, 2013
Primary Completion (ANTICIPATED)
December 1, 2015
Study Completion (ANTICIPATED)
December 1, 2015
Study Registration Dates
First Submitted
June 13, 2013
First Submitted That Met QC Criteria
June 17, 2013
First Posted (ESTIMATE)
June 18, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
May 28, 2015
Last Update Submitted That Met QC Criteria
May 27, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- POUDER
- U1111-1144-2013 (OTHER: WHO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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