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

• ClinicalTrials.gov Identifier: NCT01879878
• Recruitment Status: Unknown
• First Posted: June 18, 2013
• Last Update Posted: May 28, 2015
• Sponsor: Heidelberg University
• Collaborator: German Cancer Research Center
• Information provided by (Responsible Party): Peter Schemmer, Heidelberg University

Tracking Information

• First Submitted Date: June 13, 2013
• First Posted Date: June 18, 2013
• Last Update Posted Date: May 28, 2015
• Study Start Date: December 2013
• Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 26, 2014)

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

Original Primary Outcome Measures (submitted: June 17, 2013)

Overall Survival [ Time Frame: one year ]

Main objective is to establish evidence that broccoli sprouts rich in sulforaphane and quercetin as nutritional supplements increase the overall survival of patients with pancreatic ductal adenocarcinoma treated with conventional cytoreductive (radio-) chemotherapy.

Current Secondary Outcome Measures (submitted: May 26, 2014)

Disease status (imaging and tumor markers) [ Time Frame: One year ]

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.

Original Secondary Outcome Measures (submitted: June 17, 2013)

disease status (imaging and tumor markers) [ Time Frame: one year ]

Disease status (cancer progress or regress): CT-imaging staging and serum tumor markers (CEA and CA-19-9) peaks as additional parameters that provide insight into disease status.

Current Other Pre-specified Outcome Measures (submitted: May 26, 2014)

Substance bioavailability [ Time Frame: One year ]

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.

Original Other Pre-specified Outcome Measures (submitted: June 17, 2013)

Substance bioavailability [ Time Frame: one year ]

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.

Descriptive Information

• Brief Title: Pilot Study Evaluating Broccoli Sprouts in Advanced Pancreatic Cancer [POUDER Trial]
• Official Title: Pilot Study Evaluating Broccoli Sprouts in Advanced Pancreatic Cancer [POUDER Trial]
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Pancreatic Ductal Adenocarcinoma

Intervention

• Dietary Supplement: 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.
  Other Name: glucoraphanin
• Dietary Supplement: placebo
  Patients assigned to the placebo group will receive inactive substance (methylcellulose) with identical capsule and portion distribution as the experimental arm.

Study Arms

• Experimental: Verum, broccoli sprout grain
  Active sulforaphane distributed in capsules each containing broccoli sprout grain
  Intervention: Dietary Supplement: Verum, broccoli sprout grain
• Placebo Comparator: Placebo
  Inactive substances (methylcellulose) with identical capsule and portion distribution
  Intervention: Dietary Supplement: placebo

• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 17, 2013): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2015
• Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT01879878
• Other Study ID Numbers: POUDER; U1111-1144-2013 ( Other Identifier: WHO )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Peter Schemmer, Heidelberg University
• Original Responsible Party: Same as current
• Current Study Sponsor: Heidelberg University
• Original Study Sponsor: Same as current
• Collaborators: German Cancer Research Center

Investigators

• Study Director: Peter Schemmer, Prof. Dr. med.; Heidelberg University
• Principal Investigator: Ingrid Herr, Prof. Dr.; Heidelberg University

• PRS Account: Heidelberg University
• Verification Date: May 2015