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Spots Global Cancer Trial Database for Broccoli Sprout Extract in Treating Patients With Transitional Cell Bladder Cancer Undergoing Surgery

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Trial Identification

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

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

Study ID: NCT01108003

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Roswell Park Cancer Institute, Buffalo, New York, United States

Contact Details

Name: James Marshall, PhD

Affiliation: Roswell Park Cancer Institute

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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