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Pilot Study Evaluating Broccoli Sprouts in Advanced Pancreatic Cancer [POUDER Trial] (POUDER)

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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
Sponsor:
Collaborator:
German Cancer Research Center
Information provided by (Responsible Party):
Peter Schemmer, Heidelberg University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Ductal Adenocarcinoma Dietary Supplement: Verum, broccoli sprout grain Dietary Supplement: placebo Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01879878


Contacts
Contact: Peter Schemmer, Prof. Dr. med. +49 6221 566205 peter.schemmer@med.uni-heidelberg.de
Contact: Vladimir J. Lozanovski, M.D. +49 6221 5636439 vladimir.lozanovski@med.uni-heidelberg.de

Locations
Germany
Dept. of General and Transplant Surgery, University Hospital of Heidelberg, Germany Recruiting
Heidelberg, Germany, 69120
Contact: Vladimir J. Lozanovski, M.D.    +49 6221 5636439    vladimir.lozanovski@med.uni-heidelberg.de   
Sub-Investigator: Vladimir J. Lozanovski, M.D.         
Sponsors and Collaborators
Heidelberg University
German Cancer Research Center
Investigators
Study Director: Peter Schemmer, Prof. Dr. med. Heidelberg University
Principal Investigator: Ingrid Herr, Prof. Dr. Heidelberg University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Schemmer, Prof. Dr. med. Peter Schemmer, MBA, Heidelberg University
ClinicalTrials.gov Identifier: NCT01879878     History of Changes
Other Study ID Numbers: POUDER
U1111-1144-2013 ( Other Identifier: WHO )
First Posted: June 18, 2013    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by Peter Schemmer, Heidelberg University:
pancreatic adenocarcinoma
broccoli sprouts
sulforaphane
palliative chemotherapy
cancer stem cells

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Sulforafan
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents