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

NCT ID: NCT01879878

Last Updated: 2015-05-28

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Pancreatic Ductal Adenocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Verum, broccoli sprout grain

Active sulforaphane distributed in capsules each containing broccoli sprout grain

Group Type EXPERIMENTAL

Verum, broccoli sprout grain

Intervention Type DIETARY_SUPPLEMENT

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DIETARY_SUPPLEMENT

placebo

Patients assigned to the placebo group will receive inactive substance (methylcellulose) with identical capsule and portion distribution as the experimental arm.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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glucoraphanin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Cancer Research Center

OTHER

Sponsor Role collaborator

Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Peter Schemmer

Prof. Dr. med. Peter Schemmer, MBA

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Peter Schemmer, Prof. Dr. med.

Role: CONTACT

+49 6221 566205

Vladimir J. Lozanovski, M.D.

Role: CONTACT

+49 6221 5636439

Facility Contacts

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Vladimir J. Lozanovski, M.D.

Role: primary

+49 6221 5636439

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.

Reference Type DERIVED
PMID: 24894410 (View on PubMed)

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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