Pilot Study Evaluating Broccoli Sprouts in Advanced Pancreatic Cancer [POUDER Trial]
NCT ID: NCT01879878
Last Updated: 2015-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2013-12-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Verum, broccoli sprout grain
Active sulforaphane distributed in capsules each containing broccoli sprout grain
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.
Placebo
Inactive substances (methylcellulose) with identical capsule and portion distribution
placebo
Patients assigned to the placebo group will receive inactive substance (methylcellulose) with identical capsule and portion distribution as the experimental arm.
Interventions
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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.
placebo
Patients assigned to the placebo group will receive inactive substance (methylcellulose) with identical capsule and portion distribution as the experimental arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Intact gastric emptying
* Written informed consent
* Patients ≥18 years of age
* Palliative chemotherapy
Exclusion Criteria
* Impaired mental status or language problems / barriers
18 Years
ALL
No
Sponsors
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German Cancer Research Center
OTHER
Heidelberg University
OTHER
Responsible Party
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Peter Schemmer
Prof. Dr. med. Peter Schemmer, MBA
Principal Investigators
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Peter Schemmer, Prof. Dr. med.
Role: STUDY_DIRECTOR
Heidelberg University
Ingrid Herr, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Heidelberg University
Locations
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Dept. of General and Transplant Surgery, University Hospital of Heidelberg, Germany
Heidelberg, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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U1111-1144-2013
Identifier Type: OTHER
Identifier Source: secondary_id
POUDER
Identifier Type: -
Identifier Source: org_study_id
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