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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
Sponsor:
Collaborators:
Johns Hopkins University
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (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
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I Arm 2
Hide Arm/Group Description

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

Patients receive mango juice alone.

Mango Juice: given orally

Period Title: Overall Study
Started 4 3
Completed 4 3
Not Completed 0 0
Arm/Group Title Arm I Arm 2 Total
Hide Arm/Group Description

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

Patients receive mango juice alone.

Mango Juice: given orally

Total of all reporting groups
Overall Number of Baseline Participants 4 3 7
Hide Baseline Analysis Population Description
All treated and eligible patients
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
4
 100.0%
3
 100.0%
7
 100.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 3 participants 7 participants
74  (5.3) 73  (4.9) 74  (4.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
Female
1
  25.0%
0
   0.0%
1
  14.3%
Male
3
  75.0%
3
 100.0%
6
  85.7%
1.Primary Outcome
Title Toxicity as Assessed by National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0
Hide Description Number of participants with an adverse event.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients.
Arm/Group Title Arm I Arm 2
Hide Arm/Group Description:

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

Patients receive mango juice alone.

Mango Juice: given orally

Overall Number of Participants Analyzed 4 3
Measure Type: Number
Unit of Measure: participants
4 3
2.Secondary Outcome
Title Apoptosis, Cell Proliferation, and Microvessel Density
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the study's early termination and low accrual, data were not collected for this assessment.
Arm/Group Title Arm I Arm 2
Hide Arm/Group Description:

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

Patients receive mango juice alone.

Mango Juice: given orally

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I Arm 2
Hide Arm/Group Description

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

Patients receive mango juice alone.

Mango Juice: given orally

All-Cause Mortality
Arm I Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Arm I Arm 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/4 (50.00%)      1/3 (33.33%)    
Infections and infestations     
Fungaemia   1/4 (25.00%)  1 0/3 (0.00%)  0
Sepsis   0/4 (0.00%)  0 1/3 (33.33%)  1
Urosepsis   1/4 (25.00%)  1 0/3 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I Arm 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      3/3 (100.00%)    
Blood and lymphatic system disorders     
Anaemia   2/4 (50.00%)  3 2/3 (66.67%)  2
Lymphopenia   1/4 (25.00%)  1 0/3 (0.00%)  0
Gastrointestinal disorders     
Constipation   2/4 (50.00%)  2 2/3 (66.67%)  2
Ileus   1/4 (25.00%)  1 0/3 (0.00%)  0
Nausea   2/4 (50.00%)  2 0/3 (0.00%)  0
General disorders     
Pain   3/4 (75.00%)  3 0/3 (0.00%)  0
Pyrexia   1/4 (25.00%)  1 0/3 (0.00%)  0
Infections and infestations     
Skin infection   0/4 (0.00%)  0 1/3 (33.33%)  1
Investigations     
Aspartate aminotransferase increased   0/4 (0.00%)  0 1/3 (33.33%)  1
Blood albumin decreased   1/4 (25.00%)  1 1/3 (33.33%)  1
Blood alkaline phosphatase increased   1/4 (25.00%)  1 0/3 (0.00%)  0
Blood calcium decreased   1/4 (25.00%)  1 0/3 (0.00%)  0
Blood creatinine increased   1/4 (25.00%)  2 1/3 (33.33%)  1
Blood magnesium increased   0/4 (0.00%)  0 1/3 (33.33%)  1
Cardiac enzymes increased   1/4 (25.00%)  1 0/3 (0.00%)  0
Electrocardiogram abnormal   1/4 (25.00%)  1 0/3 (0.00%)  0
Haemoglobin decreased   1/4 (25.00%)  2 1/3 (33.33%)  1
Lymphocyte count decreased   2/4 (50.00%)  8 3/3 (100.00%)  3
Platelet count decreased   1/4 (25.00%)  2 0/3 (0.00%)  0
White blood cell analysis increased   0/4 (0.00%)  0 1/3 (33.33%)  1
Metabolism and nutrition disorders     
Hyperglycaemia   3/4 (75.00%)  3 3/3 (100.00%)  3
Hypermagnesaemia   1/4 (25.00%)  1 0/3 (0.00%)  0
Hyperphosphataemia   0/4 (0.00%)  0 1/3 (33.33%)  1
Hypocalcaemia   1/4 (25.00%)  1 3/3 (100.00%)  3
Hypokalaemia   1/4 (25.00%)  1 1/3 (33.33%)  1
Hypomagnesaemia   1/4 (25.00%)  1 0/3 (0.00%)  0
Hyponatraemia   1/4 (25.00%)  1 3/3 (100.00%)  3
Hypophosphataemia   1/4 (25.00%)  1 0/3 (0.00%)  0
Psychiatric disorders     
Confusional state   0/4 (0.00%)  0 1/3 (33.33%)  1
Renal and urinary disorders     
Haematuria   1/4 (25.00%)  1 0/3 (0.00%)  0
Reproductive system and breast disorders     
Penile discharge   0/4 (0.00%)  0 1/3 (33.33%)  1
Skin and subcutaneous tissue disorders     
Pruritus   1/4 (25.00%)  1 0/3 (0.00%)  0
Indicates events were collected by systematic assessment
Due to the study's early termination and low accrual, data were not collected for all study objectives assessment.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
Phone: 716-845-2300
Layout table for additonal information
Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01108003    
Other Study ID Numbers: I 129408
NCI-2010-00759
First Submitted: April 19, 2010
First Posted: April 21, 2010
Results First Submitted: May 16, 2016
Results First Posted: June 23, 2016
Last Update Posted: June 26, 2017