Trial Outcomes & Findings for Broccoli Sprout Extract in Treating Patients With Transitional Cell Bladder Cancer Undergoing Surgery (NCT NCT01108003)
NCT ID: NCT01108003
Last Updated: 2017-06-26
Results Overview
Number of participants with an adverse event.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
14 days
Results posted on
2017-06-26
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Broccoli Sprout Extract in Treating Patients With Transitional Cell Bladder Cancer Undergoing Surgery
Baseline characteristics by cohort
| Measure |
Arm I
n=4 Participants
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
n=3 Participants
Patients receive mango juice alone.
Mango Juice: given orally
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
74 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
73 years
STANDARD_DEVIATION 4.9 • n=7 Participants
|
74 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: All treated and eligible patients.
Number of participants with an adverse event.
Outcome measures
| Measure |
Arm I
n=4 Participants
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
n=3 Participants
Patients receive mango juice alone.
Mango Juice: given orally
|
|---|---|---|
|
Toxicity as Assessed by National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0
|
4 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Due to the study's early termination and low accrual, data were not collected for this assessment.
Outcome measures
Outcome data not reported
Adverse Events
Arm I
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm 2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I
n=4 participants at risk
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
n=3 participants at risk
Patients receive mango juice alone.
Mango Juice: given orally
|
|---|---|---|
|
Infections and infestations
Fungaemia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Infections and infestations
Sepsis
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
|
Infections and infestations
Urosepsis
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
Other adverse events
| Measure |
Arm I
n=4 participants at risk
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
n=3 participants at risk
Patients receive mango juice alone.
Mango Juice: given orally
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
2/4 • Number of events 3
|
66.7%
2/3 • Number of events 2
|
|
Blood and lymphatic system disorders
Lymphopenia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • Number of events 2
|
66.7%
2/3 • Number of events 2
|
|
Gastrointestinal disorders
Ileus
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Number of events 2
|
0.00%
0/3
|
|
General disorders
Pain
|
75.0%
3/4 • Number of events 3
|
0.00%
0/3
|
|
General disorders
Pyrexia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Infections and infestations
Skin infection
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
|
Investigations
Blood albumin decreased
|
25.0%
1/4 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Investigations
Blood alkaline phosphatase increased
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Investigations
Blood calcium decreased
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Investigations
Blood creatinine increased
|
25.0%
1/4 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
|
Investigations
Blood magnesium increased
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
|
Investigations
Cardiac enzymes increased
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Investigations
Electrocardiogram abnormal
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Investigations
Haemoglobin decreased
|
25.0%
1/4 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
50.0%
2/4 • Number of events 8
|
100.0%
3/3 • Number of events 3
|
|
Investigations
Platelet count decreased
|
25.0%
1/4 • Number of events 2
|
0.00%
0/3
|
|
Investigations
White blood cell analysis increased
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
75.0%
3/4 • Number of events 3
|
100.0%
3/3 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
25.0%
1/4 • Number of events 1
|
100.0%
3/3 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
1/4 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
1/4 • Number of events 1
|
100.0%
3/3 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Reproductive system and breast disorders
Penile discharge
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place