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History of Changes for Study: NCT01879878
Pilot Study Evaluating Broccoli Sprouts in Advanced Pancreatic Cancer (POUDER)
Latest version (submitted May 27, 2015) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 17, 2013 None (earliest Version on record)
2 October 27, 2013 Study Status, Outcome Measures, Eligibility and Study Description
3 May 8, 2014 Study Status, Conditions and Study Identification
4 May 26, 2014 Recruitment Status, Contacts/Locations, Outcome Measures, Study Status, Arms and Interventions and Study Identification
5 May 27, 2015 Recruitment Status and Study Status
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Study NCT01879878
Submitted Date:  June 17, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: POUDER
Brief Title: Pilot Study Evaluating Broccoli Sprouts in Advanced Pancreatic Cancer (POUDER)
Official Title: Pilot Study Evaluating Broccoli Sprouts in Advanced Pancreatic Cancer (POUDER)
Secondary IDs: U1111-1144-2013 [WHO]
Open or close this module Study Status
Record Verification: June 2013
Overall Status: Not yet recruiting
Study Start: July 2013
Primary Completion: July 2014 [Anticipated]
Study Completion: December 2014 [Anticipated]
First Submitted: June 13, 2013
First Submitted that
Met QC Criteria:
June 17, 2013
First Posted: June 18, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 17, 2013
Last Update Posted: June 18, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Heidelberg University
Responsible Party: Principal Investigator
Investigator: Peter Schemmer
Official Title: Prof. Dr. med. Peter Schemmer, MBA
Affiliation: Heidelberg University
Collaborators: German Cancer Research Center
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The goal of the POUDER trial is to determine whether broccoli sprouts rich in sulforaphane and quercetin as nutritional supplement positively affect the overall survival of surgically non-treatable patients with pancreatic ductal adenocarcinoma that receive conventional cytoreductive (radio-) 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.
Open or close this module Conditions
Conditions: Pancreatic Ductal Adenocarcinoma
Keywords: pancreatic ductal adenocarcinoma
broccoli sprouts
sulforaphane
quercetin
chemotherapy
cancer stem cells
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 40 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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 Names:
  • glucoraphanin
Placebo Comparator: Placebo
inactive substances (methylcellulose) with identical capsule and portion distribution
Dietary Supplement: placebo
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Overall Survival
[ Time Frame: one year ]

Main objective is to establish evidence that broccoli sprouts rich in sulforaphane and quercetin as nutritional supplements increase the overall survival of patients with pancreatic ductal adenocarcinoma treated with conventional cytoreductive (radio-) chemotherapy.
Secondary Outcome Measures:
1. disease status (imaging and tumor markers)
[ Time Frame: one year ]

Disease status (cancer progress or regress): CT-imaging staging and serum tumor markers (CEA and CA-19-9) peaks as additional parameters that provide insight into disease status.
Other Outcome Measures:
1. 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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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)
  • written informed consent
  • patients ≥18 years of age

Exclusion Criteria:

  • Intolerance to broccoli or its ingredients
Open or close this module Contacts/Locations
Central Contact Person: Peter Schemmer, Prof.Dr.med.
Telephone: +49 6221 566205
Email: peter.schemmer@med.uni-heidelberg.de
Central Contact Backup: Vladimir J Lozanovski
Telephone: +49 6221 5636439
Email: vladimir.lozanovski@med.uni-heidelberg.de
Study Officials: Peter Schemmer, Prof.Dr.med.
Study Director
Heidelberg University
Ingrid Herr, Prof. Dr.
Principal Investigator
Heidelberg University
Locations: Germany
Dept. of General, Visceral and Transplant Surgery, University Hospital of Heidelberg, Germany
Heidelberg, Germany, 69120
Contact:Contact: Vladimir J Lozanovski +49 6221 5636439 vladimir.lozanovski@med.uni-heidelberg.de
Contact:Sub-Investigator: Vladimir J Lozanovski
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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