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

Heidelberg University

Status: Unknown

Conditions: Pancreatic Ductal Adenocarcinoma

Treatments: Dietary Supplement: Verum, broccoli sprout grain; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01879878

POUDER

U1111-1144-2013 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Verum, broccoli sprout grain

Experimental group

Description:

Active sulforaphane distributed in capsules each containing broccoli sprout grain

Treatment:

Dietary Supplement: Verum, broccoli sprout grain

Placebo

Placebo Comparator group

Description:

Inactive substances (methylcellulose) with identical capsule and portion distribution

Treatment:

Dietary Supplement: placebo