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Trial record 1 of 1 for:    NCT01108003
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Broccoli Sprout Extract in Treating Patients With Transitional Cell Bladder Cancer Undergoing Surgery

This study has been terminated.
(low accrual)
Sponsor:
Collaborators:
Johns Hopkins University
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01108003
First received: April 19, 2010
Last updated: May 16, 2016
Last verified: May 2016
Results First Received: May 16, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Bladder Cancer
Stage 0 Bladder Cancer
Stage I Bladder Cancer
Stage II Bladder Cancer
Transitional Cell Carcinoma of the Bladder
Interventions: Drug: broccoli sprout extract
Other: laboratory biomarker analysis
Other: Mango Juice

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm I

Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.

broccoli sprout extract: Given orally

laboratory biomarker analysis: Correlative studies

Arm 2

Patients receive mango juice alone.

Mango Juice: given orally


Participant Flow:   Overall Study
    Arm I     Arm 2  
STARTED     4     3  
COMPLETED     4     3  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All treated and eligible patients

Reporting Groups
  Description
Arm I

Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.

broccoli sprout extract: Given orally

laboratory biomarker analysis: Correlative studies

Arm 2

Patients receive mango juice alone.

Mango Juice: given orally

Total Total of all reporting groups

Baseline Measures
    Arm I     Arm 2     Total  
Number of Participants  
[units: participants]
  4     3     7  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     0     0     0  
>=65 years     4     3     7  
Age  
[units: years]
Mean (Standard Deviation)
  74  (5.3)     73  (4.9)     74  (4.7)  
Gender  
[units: participants]
     
Female     1     0     1  
Male     3     3     6  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Toxicity as Assessed by National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0   [ Time Frame: 14 days ]

2.  Secondary:   Apoptosis, Cell Proliferation, and Microvessel Density   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Due to the study's early termination and low accrual, data were not collected for all study objectives assessment.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
phone: 716-845-2300



Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01108003     History of Changes
Other Study ID Numbers: I 129408
NCI-2010-00759
Study First Received: April 19, 2010
Results First Received: May 16, 2016
Last Updated: May 16, 2016
Health Authority: United States: Food and Drug Administration