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


N/A
18 Years
N/A
Not Enrolling
Both
Pancreatic Ductal Adenocarcinoma

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Trial Information

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


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.


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)

- written informed consent

- patients ≥18 years of age

Exclusion Criteria:

- Intolerance to broccoli or its ingredients

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Survival

Outcome Description:

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.

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Peter Schemmer, Prof.Dr.med.

Investigator Role:

Study Director

Investigator Affiliation:

University of Heidelberg

Authority:

Germany: Ethics Commission

Study ID:

POUDER

NCT ID:

NCT01879878

Start Date:

July 2013

Completion Date:

December 2014

Related Keywords:

  • Pancreatic Ductal Adenocarcinoma
  • pancreatic ductal adenocarcinoma
  • broccoli sprouts
  • sulforaphane
  • quercetin
  • chemotherapy
  • cancer stem cells
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms
  • Carcinoma, Ductal, Breast

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