Broccoli Sprout Extract in Treating Patients With Transitional Cell Bladder Cancer Undergoing Sur… (NCT01108003) | Clinical Trial Compass
TerminatedNot Applicable
Broccoli Sprout Extract in Treating Patients With Transitional Cell Bladder Cancer Undergoing Surgery
Stopped: low accrual
United States7 participantsStarted 2010-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Any patient eligible for superficial bladder cancer
* Patients must be considered fit for surgical resection with curative intent
* No chemotherapy, surgery (excluding transurethral resection of bladder tumor \[TURBT\], BCG or radiotherapy in the prior 4 weeks \[6 weeks for mitomycin C or interferon\])
* No previous treatment/ingestion with broccoli extracts
* Eastern Oncology Group (ECOG) performance status 0-2
* AST and ALT =\< 2.5 times ULN (upper limit of normal)
* Total bilirubin =\< 2.0 mg/dL
* Creatinine Clearance \>= 30 ml/min
* WBC \> 3000 mm\^3
* Absolute neutrophil count \> 1000/mm\^3
* Platelets \> 100,000/mm\^3
* All patients must sign a study-specific consent form indicating that they are aware of the investigational nature of this study
Exclusion Criteria:
* Have participated in any clinical trial involving conventional or investigational drugs or devices within the previous 4 weeks
* Prior radiation to the pelvis
* Intractable urinary tract infection that has not responded to antibiotic treatment
* Active, uncontrolled bacterial, viral, or fungal infection including HIV
* Have had major surgery within 4 weeks of starting therapy (not including placement of vascular access device or TURBT)
* Poor medical risk in the opinion of the treating oncologist due to non-malignant systemic disease
* Pregnant or lactating patients: patients must be postmenopausal or practicing an accepted form of birth control; for patients where pregnancy is a po…
What they're measuring
1
Toxicity as Assessed by National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0