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

Not Applicable

• Conditions: Pancreatic Ductal Adenocarcinoma
• Interventions: Dietary Supplement: Verum, broccoli sprout grain; Dietary Supplement: placebo

• Registration Number: NCT01879878
• Lead Sponsor: Heidelberg University

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 Timeline

• Study First Submitted: 2013-06-13
• Study First Submitted QC: 2013-06-17
• Study First Posted: 2013-06-18
• Study Start: 2013-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-27
• Last Update Posted: 2015-05-28
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verum, broccoli sprout grain	Verum, broccoli sprout grain	Active sulforaphane distributed in capsules each containing broccoli sprout grain
Placebo	placebo	Inactive substances (methylcellulose) with identical capsule and portion distribution

Primary Outcome Measures

Name	Time	Method
Feasibility of a randomized controlled trial	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

Secondary Outcome Measures

Name	Time	Method
Disease status (imaging and tumor markers)	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.

Trial Locations

Locations (1)

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