Broccoli Sprout Extract in Treating Patients With Transitional Cell Bladder Cancer Undergoing Surgery
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|ClinicalTrials.gov Identifier: NCT01108003|
Recruitment Status : Terminated (low accrual)
First Posted : April 21, 2010
Results First Posted : June 23, 2016
Last Update Posted : June 26, 2017
Rationale: Broccoli sprout extract contains ingredients that may prevent or slow the growth of certain cancers.
Purpose: This pilot study is studying the side effects of broccoli sprout extract in treating patients with transitional cell bladder cancer undergoing surgery.
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Bladder Cancer Stage 0 Bladder Cancer Stage I Bladder Cancer Stage II Bladder Cancer Transitional Cell Carcinoma of the Bladder||Drug: broccoli sprout extract Other: laboratory biomarker analysis Other: Mango Juice||Not Applicable|
I. To determine the tolerability and toxicity of a broccoli sprout extract (providing 200 micro mol isothiocyanate/dose/per day) given for 14 days in patients destined to undergo definitive bladder resection for bladder cancer.
I. Establish the safety of administration of the broccoli extract on the bladder surgery specifically.
II. Determine the levels of isothiocyanates and their metabolites in urine, blood, benign urothelium and bladder cancer tissue.
III. Assess the antitumor effects of broccoli extract on the primary bladder tumor by measuring angiogenesis, cell proliferation and apoptosis.
IV. Determine the feasibility of treating patients with 200 micro mol isothiocyanate per dose per day of broccoli sprout extract in future therapeutic and prevention clinical trials.
Outline: Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 4 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Pre-cystectomy Trial of Broccoli Extract in Patients With Superficial or Locally Advanced Bladder Cancer|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||October 2015|
Experimental: Arm I
Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.
Drug: broccoli sprout extract
Other: laboratory biomarker analysis
Placebo Comparator: Arm 2
Patients receive mango juice alone.
Other: Mango Juice
- Toxicity as Assessed by National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0 [ Time Frame: 14 days ]Number of participants with an adverse event.
- Apoptosis, Cell Proliferation, and Microvessel Density [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01108003
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Principal Investigator:||James Marshall, PhD||Roswell Park Cancer Institute|