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

Pancreatic Ductal Adenocarcinoma Clinical Trial

— POUDER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01879878
• Other study ID #: POUDER
• Secondary ID: U1111-1144-2013
• Status: Recruiting
• Phase: N/A
• First received: June 13, 2013
• Last updated: May 27, 2015
• Start date: December 2013
• Est. completion date: December 2015

Study information

• Verified date: May 2015
• Source: Heidelberg University
• Contact: Peter Schemmer, Prof. Dr. med.
• Phone: +49 6221 566205
• Email: peter.schemmer[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma
• Pancreatic Neoplasms

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

Locations

Country	Name	City	State
Germany	Dept. of General and Transplant Surgery, University Hospital of Heidelberg, Germany	Heidelberg

Sponsors (2)

Lead Sponsor	Collaborator
Heidelberg University	German Cancer Research Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Substance bioavailability	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.	One year	No
Primary	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	No
Secondary	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.	One year	No