Pancreatic Ductal AdenocarcinomaPOUDERNCT01879878
Pilot Study Evaluating Broccoli Sprouts in Advanced Pancreatic Cancer [POUDER Trial]
A study testing Verum, broccoli sprout grain in people with Pancreatic Ductal Adenocarcinoma, run by Heidelberg University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Verum, broccoli sprout grain
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Intolerance to broccoli or its ingredients
- Impaired mental status or language problems / barriers
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Dept. of General and Transplant Surgery, University Hospital of Heidelberg, Germany
Heidelberg, 69120
Vladimir J. Lozanovski, M.D., +49 6221 5636439, vladimir.lozanovski@med.uni-heidelberg.de
Vladimir J. Lozanovski, M.D.
About this study
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.
Read the 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.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- Verum, broccoli sprout grain, placebo
- Keywords
- pancreatic adenocarcinoma, broccoli sprouts, sulforaphane, palliative chemotherapy, cancer stem cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verum, broccoli sprout grainDietary supplement
Also called glucoraphanin
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.
placeboDietary supplement
Patients assigned to the placebo group will receive inactive substance (methylcellulose) with identical capsule and portion distribution as the experimental arm.
| Study group | Role | What they receive |
|---|---|---|
| Verum, broccoli sprout grain | Experimental | Active sulforaphane distributed in capsules each containing broccoli sprout grain Receives: Dietary Supplement: Verum, broccoli sprout grain |
| Placebo | Placebo comparator | Inactive substances (methylcellulose) with identical capsule and portion distribution Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One year
Secondary outcomes (1)
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- German Cancer Research Center
- Responsible party
- Principal investigator, Peter Schemmer, Heidelberg University
- Investigators
- Peter Schemmer, Prof. Dr. med., Study director, Heidelberg UniversityIngrid Herr, Prof. Dr., Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879878
- Sponsor's protocol ID
- POUDER
- Other IDs
- U1111-1144-2013
- Acronym
- POUDER
- Status last verified
- May 2015
- First submitted
- 13 Jun 2013
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24894410
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating Broccoli Sprouts in Advanced Pancreatic Cancer [POUDER Trial]
- ClinicalTrials.gov ID
- NCT01879878
- Acronym / sponsor ID
- POUDER / POUDER
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Keywords
- pancreatic adenocarcinoma, broccoli sprouts, sulforaphane, palliative chemotherapy, cancer stem cells
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- German Cancer Research Center
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 18 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum, broccoli sprout grain | Experimental | Dietary Supplement: Verum, broccoli sprout grainActive sulforaphane distributed in capsules each containing broccoli sprout grain |
| Placebo | Placebo comparator | Dietary Supplement: placeboInactive substances (methylcellulose) with identical capsule and portion distribution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Intolerance to broccoli or its ingredients
- Impaired mental status or language problems / barriers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verum, broccoli sprout grainAlso: glucoraphaninPatients 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. | Dietary supplement | Verum, broccoli sprout grain |
| placeboPatients assigned to the placebo group will receive inactive substance (methylcellulose) with identical capsule and portion distribution as the experimental arm. | Dietary supplement | Placebo |
Primary outcome
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
1 secondary outcome
Disease status (imaging and tumor markers)
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Derived from this study: PubMed 24894410Lozanovski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Schemmer, Prof. Dr. med. study director
Heidelberg University
Ingrid Herr, Prof. Dr. principal investigator
Heidelberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verum, broccoli sprout grain in people with Pancreatic Ductal Adenocarcinoma, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Schemmer, Prof. Dr. med. (+49 6221 566205, peter.schemmer@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of a randomized controlled trial (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01879878, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.