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

Primary Purpose

Pancreatic Ductal Adenocarcinoma

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Verum, broccoli sprout grain
placebo
Sponsored by
Heidelberg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Ductal Adenocarcinoma focused on measuring pancreatic adenocarcinoma, broccoli sprouts, sulforaphane, palliative chemotherapy, cancer stem cells

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept. of General and Transplant Surgery, University Hospital of Heidelberg, GermanyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Verum, broccoli sprout grain

Placebo

Arm Description

Active sulforaphane distributed in capsules each containing broccoli sprout grain

Inactive substances (methylcellulose) with identical capsule and portion distribution

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
June 13, 2013
Last Updated
May 27, 2015
Sponsor
Heidelberg University
Collaborators
German Cancer Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT01879878
Brief Title
Pilot Study Evaluating Broccoli Sprouts in Advanced Pancreatic Cancer [POUDER Trial]
Acronym
POUDER
Official Title
Pilot Study Evaluating Broccoli Sprouts in Advanced Pancreatic Cancer [POUDER Trial]
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University
Collaborators
German Cancer Research Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Ductal Adenocarcinoma
Keywords
pancreatic adenocarcinoma, broccoli sprouts, sulforaphane, palliative chemotherapy, cancer stem cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Verum, broccoli sprout grain
Arm Type
Experimental
Arm Description
Active sulforaphane distributed in capsules each containing broccoli sprout grain
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Inactive substances (methylcellulose) with identical capsule and portion distribution
Intervention Type
Dietary Supplement
Intervention Name(s)
Verum, broccoli sprout grain
Other Intervention Name(s)
glucoraphanin
Intervention 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
Patients assigned to the placebo group will receive inactive substance (methylcellulose) with identical capsule and portion distribution as the experimental arm.
Primary Outcome Measure Information:
Title
Feasibility of a randomized controlled trial
Description
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
Time Frame
One year
Secondary Outcome Measure Information:
Title
Disease status (imaging and tumor markers)
Description
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.
Time Frame
One year
Other Pre-specified Outcome Measures:
Title
Substance bioavailability
Description
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.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Schemmer, Prof. Dr. med.
Phone
+49 6221 566205
Email
peter.schemmer@med.uni-heidelberg.de
First Name & Middle Initial & Last Name or Official Title & Degree
Vladimir J. Lozanovski, M.D.
Phone
+49 6221 5636439
Email
vladimir.lozanovski@med.uni-heidelberg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Schemmer, Prof. Dr. med.
Organizational Affiliation
Heidelberg University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ingrid Herr, Prof. Dr.
Organizational Affiliation
Heidelberg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of General and Transplant Surgery, University Hospital of Heidelberg, Germany
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vladimir J. Lozanovski, M.D.
Phone
+49 6221 5636439
Email
vladimir.lozanovski@med.uni-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Vladimir J. Lozanovski, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
24894410
Citation
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.
Results Reference
derived

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

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