NCT01108003

Broccoli Sprout Extract in Treating Patients With Transitional Cell Bladder Cancer Undergoing Surgery

Pilot Pre-cystectomy Trial of Broccoli Extract in Patients With Superficial or Locally Advanced Bladder Cancer

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Primary Objectives: 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. Secondary Objectives: 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.

Conditions

• Recurrent Bladder Cancer
• Stage 0 Bladder Cancer
• Stage I Bladder Cancer
• Stage II Bladder Cancer
• Transitional Cell Carcinoma of the Bladder

Interventions

Type	Name	Description
DRUG	broccoli sprout extract	Given orally
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	Mango Juice	given orally

Timeline

• Start date: 2010-04-01
• Primary completion: 2014-09-01
• Completion: 2015-10-01
• First posted: 2010-04-21
• Last updated: 2017-06-26
• Results posted: 2016-06-23

Locations

1 site across 1 country: United States