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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pancreatic Ductal Adenocarcinoma

Intervention / Treatment
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* Dietary Supplement: Verum, broccoli sprout grain
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum, broccoli sprout grain<br>Active sulforaphane distributed in capsules each containing broccoli sprout grain | Dietary Supplement: Verum, broccoli sprout grain<br>* 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.<br>* Other names: glucoraphanin;|
| Placebo Comparator: Placebo<br>Inactive substances (methylcellulose) with identical capsule and portion distribution | Dietary Supplement: placebo<br>* Patients assigned to the placebo group will receive inactive substance (methylcellulose) with identical capsule and portion distribution as the experimental arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatic adenocarcinoma, broccoli sprouts, sulforaphane, palliative chemotherapy, cancer stem cells