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

View this study on Beta.ClinicalTrials.gov

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

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Arm I	Arm 2
Arm/Group Description	Patients receive oral broccoli spro...	Patients receive mango juice alone....
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

Baseline Characteristics

Arm/Group Title		Arm I	Arm 2	Total
Arm/Group Description		Patients receive oral broccoli spro...	Patients receive mango juice alone....	Total of all reporting groups
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
Baseline Analysis Population Description		...
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%

Outcome Measures

1.Primary Outcome


Title	Toxicity as Assessed by National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0
Description	Number of participants with an adverse event.
Description	Number of participants with an adverse event.
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

All treated and eligible patients.


Arm/Group Title	Arm I	Arm 2
Arm/Group Description:	Patients receive oral broccoli spro...	Patients receive mango juice alone....
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
Description	[Not Specified]
Description	[Not Specified]
Time Frame	1 year

Outcome Measure Data

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
Arm/Group Description:	Patients receive oral broccoli spro...	Patients receive mango juice alone....
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.

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Arm I		Arm 2
Arm/Group Description	Patients receive oral broccoli spro...		Patients receive mango juice alone....
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	--/--		--/--
Serious Adverse Events 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
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

Limitations and Caveats

Due to the study's early termination and low accrual, data were not collected for all study objectives assessment.

More Information

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

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