NCT01879878

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

2 years

First QC Date

June 13, 2013

Last Update Submit

May 27, 2015

Conditions

Pancreatic Ductal Adenocarcinoma

Keywords

pancreatic adenocarcinomabroccoli sproutssulforaphanepalliative chemotherapycancer stem cells

Outcome Measures

Primary Outcomes (1)

  • 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

    One year

Secondary Outcomes (1)

  • Disease status (imaging and tumor markers)

    One year

Other Outcomes (1)

  • Substance bioavailability

    One year

Study Arms (2)

Verum, broccoli sprout grain

EXPERIMENTAL

Active sulforaphane distributed in capsules each containing broccoli sprout grain

Dietary Supplement: Verum, broccoli sprout grain

Placebo

PLACEBO COMPARATOR

Inactive substances (methylcellulose) with identical capsule and portion distribution

Dietary Supplement: placebo

Interventions

Verum, broccoli sprout grainDIETARY_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.

Also known as: glucoraphanin
Verum, broccoli sprout grain
placeboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Intolerance to broccoli or its ingredients
  • Impaired mental status or language problems / barriers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of General and Transplant Surgery, University Hospital of Heidelberg, Germany

Heidelberg, 69120, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 24894410DERIVED

MeSH Terms

Interventions

glucoraphanin

Study Officials

  • Peter Schemmer, Prof. Dr. med.

    Heidelberg University

    STUDY DIRECTOR

  • Ingrid Herr, Prof. Dr.

    Heidelberg University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Schemmer, Prof. Dr. med.

CONTACT

+49 6221 566205peter.schemmer@med.uni-heidelberg.de

Vladimir J. Lozanovski, M.D.

CONTACT

+49 6221 5636439vladimir.lozanovski@med.uni-heidelberg.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Peter Schemmer, MBA

Study Record Dates

First Submitted

June 13, 2013

First Posted

June 18, 2013

Study Start

December 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

DE(1)