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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

Tracking Information
First Submitted Date  ICMJE June 13, 2013
First Posted Date  ICMJE June 18, 2013
Last Update Posted Date May 28, 2015
Study Start Date  ICMJE December 2013
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2014)
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 17, 2013)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2014)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2013)
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.
Current Other Pre-specified Outcome Measures
 (submitted: May 26, 2014)
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.
Original Other Pre-specified Outcome Measures
 (submitted: June 17, 2013)
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.
 
Descriptive Information
Brief Title  ICMJE Pilot Study Evaluating Broccoli Sprouts in Advanced Pancreatic Cancer [POUDER Trial]
Official Title  ICMJE Pilot Study Evaluating Broccoli Sprouts in Advanced Pancreatic Cancer [POUDER Trial]
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Ductal Adenocarcinoma
Intervention  ICMJE
  • 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
  • Dietary Supplement: placebo
    Patients assigned to the placebo group will receive inactive substance (methylcellulose) with identical capsule and portion distribution as the experimental arm.
Study Arms  ICMJE
  • Experimental: Verum, broccoli sprout grain
    Active sulforaphane distributed in capsules each containing broccoli sprout grain
    Intervention: Dietary Supplement: Verum, broccoli sprout grain
  • Placebo Comparator: Placebo
    Inactive substances (methylcellulose) with identical capsule and portion distribution
    Intervention: Dietary Supplement: placebo
Publications * Lozanovski VJ, Houben P, Hinz U, Hackert T, Herr I, Schemmer P. Pilot study evaluating broccoli sprouts in advanced pancreatic cancer (POUDER trial) - study protocol for a randomized controlled trial. Trials. 2014 Jun 3;15:204. doi: 10.1186/1745-6215-15-204.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 17, 2013)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01879878
Other Study ID Numbers  ICMJE POUDER
U1111-1144-2013 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Peter Schemmer, Heidelberg University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Heidelberg University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE German Cancer Research Center
Investigators  ICMJE
Study Director: Peter Schemmer, Prof. Dr. med. Heidelberg University
Principal Investigator: Ingrid Herr, Prof. Dr. Heidelberg University
PRS Account Heidelberg University
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP