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@ARTICLE{Lozanovski:127974,
author = {V. J. Lozanovski and P. Houben and U. Hinz and T. Hackert
and I. Herr$^*$ and P. Schemmer},
title = {{P}ilot study evaluating broccoli sprouts in advanced
pancreatic cancer ({POUDER} trial) - study protocol for a
randomized controlled trial.},
journal = {Trials},
volume = {15},
number = {1},
issn = {1745-6215},
address = {London},
publisher = {BioMed Central},
reportid = {DKFZ-2017-03996},
pages = {204},
year = {2014},
abstract = {Pancreatic ductal adenocarcinoma (PDA) is one of the most
aggressive malignancies with marked resistance to chemo- and
radiotherapy. PDA-cancer stem cells (CSCs) are not targeted
by current therapies and may be a reason for poor prognosis.
Studies indicate that diets rich in cabbage, broccoli, and
cauliflower offer cancer preventative and therapeutic
benefits. Recent experimental studies have confirmed these
findings and demonstrated that isothiocyanate, sulforaphane,
and the polyphenol, quercetin, effectively reduced tumor
growth and enhanced the sensitivity of the cancer cells to
current chemotherapeutics. The aim of the present study is
to test the feasibility of a randomized controlled trial on
the application of freeze-dried broccoli sprouts in patients
with advanced PDA.The study is designed as a prospective
randomized, double-blinded pilot trial with a treatment and
a placebo-controlled arm in a single center setting. A total
number of forty patients (18 years or older) in two parallel
groups with advanced, surgically non-resectable PDA under
palliative chemotherapy are planned for recruitment.
Patients in the treatment group will receive fifteen
capsules of the study substance per day (90 mg of active
sulforaphane) during the chemotherapy treatment course.
Patients in the placebo group will receive the same capsule
size and portion distribution with inactive substances
(mainly methylcellulose). The follow-up duration is one
year. Feasibility of the study substance, adverse effects,
and patient compliance, as well as levels of serum tumor
markers (CEA, CA 19-9), quality of life, and patient overall
survival rates will be assessed at defined points of
time.The POUDER trial is expected to transfer promising
experimental and epidemiological data into a clinical pilot
study to assess the effectiveness of broccoli sprout
extracts in the treatment of advanced PDA. The study
objectives will provide data on the clinical feasibility and
acceptability of a supportive treatment option accompanying
palliative chemotherapy. Based on these results, future
clinical studies to create further evidence in this field
are possible.The POUDER trial has been registered at
ClinicalTrials.gov with an ID NCT01879878 and WHO with an ID
U1111-1144-2013 on June 13th 2013.},
keywords = {Antineoplastic Agents (NLM Chemicals) / Biomarkers, Tumor
(NLM Chemicals)},
cin = {G403},
ddc = {610},
cid = {I:(DE-He78)G403-20160331},
pnm = {317 - Translational cancer research (POF3-317)},
pid = {G:(DE-HGF)POF3-317},
typ = {PUB:(DE-HGF)16},
pubmed = {pmid:24894410},
pmc = {pmc:PMC4059031},
doi = {10.1186/1745-6215-15-204},
url = {https://inrepo02.dkfz.de/record/127974},
}