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TerminatedNCT01108003Updated Jun 26, 2017Results posted

Broccoli Sprout Extract in Treating Patients With Transitional Cell Bladder Cancer Undergoing Surgery

An interventional study of broccoli sprout extract and laboratory biomarker analysis in Recurrent Bladder Cancer, Stage 0 Bladder Cancer and Stage I Bladder Cancer, sponsored by Roswell Park Cancer Institute. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-26.

Sponsored by Roswell Park Cancer Institute · Not applicable, Interventional, and Treatment

Why this study was terminated
low accrual
Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Primary Objectives:

I. To determine the tolerability and toxicity of a broccoli sprout extract (providing 200 micro mol isothiocyanate/dose/per day) given for 14 days in patients destined to undergo definitive bladder resection for bladder cancer.

Secondary Objectives:

I. Establish the safety of administration of the broccoli extract on the bladder surgery specifically.

II. Determine the levels of isothiocyanates and their metabolites in urine, blood, benign urothelium and bladder cancer tissue.

III. Assess the antitumor effects of broccoli extract on the primary bladder tumor by measuring angiogenesis, cell proliferation and apoptosis.

IV. Determine the feasibility of treating patients with 200 micro mol isothiocyanate per dose per day of broccoli sprout extract in future therapeutic and prevention clinical trials.

Outline: Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 4 weeks.

02

Conditions studied

  • Recurrent Bladder Cancer
  • Stage 0 Bladder Cancer
  • Stage I Bladder Cancer
  • Stage II Bladder Cancer
  • Transitional Cell Carcinoma of the Bladder
03

In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's enrollment of 7 is below the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

Roswell Park Cancer Institute is the lead sponsor of 412 studies on the registry; 62 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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 possibility, a pregnancy test will be required prior to initiation of therapy
  • Have a history of myocardial infarction or angina pectoris/angina equivalent in the last 6 months (the patient may be on anti-anginal medications if the symptoms have been entirely controlled for greater than 6 months), or have uncontrolled congestive heart failure
  • Have a history of bleeding disorders or thrombosis; patients on therapeutic doses of anticoagulation (including coumadin or heparins) are not permitted on trial (this exclusion criterion does not include those patients receiving low dose or prophylactic dose anticoagulation [i.e. coumadin 1 mg daily in patients with central intravenous lines])
  • Radiotherapy during the course of the trial
  • Inability to tolerate proposed treatment or procedures
  • Have additional uncontrolled serious medical conditions or psychiatric illness
  • Patients with a history of hepatitis (including but not exclusive to viral hepatitis auto-immune or alcoholic)
  • Patients with active thyroid disease (patients with hypothyroidism, adequately replaced on a stable dose of thyroid replacement will be allowed on trial)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    Arm I

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

    Drug: broccoli sprout extract · Other: laboratory biomarker analysis

  • Placebo comparator
    Arm 2

    Patients receive mango juice alone.

    Other: Mango Juice

Interventions

  • Drugbroccoli sprout extract

    Given orally

  • Otherlaboratory biomarker analysis

    Correlative studies

  • OtherMango Juice

    given orally

06

What researchers measure

Primary outcomes

  1. Toxicity as Assessed by National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0

    Number of participants with an adverse event.

    Time frame: 14 days

Secondary outcomes

  1. Apoptosis, Cell Proliferation, and Microvessel Density

    Time frame: 1 year

07

Results

Posted Jun 23, 2016
Limitations and caveats
Due to the study's early termination and low accrual, data were not collected for all study objectives assessment.

Participant flow

Participant flow — Overall Study
MilestoneArm IArm 2
Started43
Completed43
Not completed00

Outcome measures

PrimaryToxicity as Assessed by National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0

Number of participants with an adverse event.

Time frame:
14 days
Reported as:
Number · participants
Toxicity as Assessed by National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0
participantsArm IArm 2
Toxicity as Assessed by National Cancer Institute (NCI) Common Toxicity Criteria Version 3.043
SecondaryApoptosis, Cell Proliferation, and Microvessel Density
Time frame:
1 year

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm I—2/4 (50%)4/4 (100%)
Arm 2—1/3 (33.3%)3/3 (100%)
Most frequent serious events
Most frequent serious events
EventArm IArm 2
SepsisInfections and infestations0/41/3
FungaemiaInfections and infestations1/40/3
UrosepsisInfections and infestations1/40/3
Most frequent other events
Showing 10 of 32
Most frequent other events
EventArm IArm 2
Lymphocyte count decreasedInvestigations2/43/3
HyperglycaemiaMetabolism and nutrition disorders3/43/3
HypocalcaemiaMetabolism and nutrition disorders1/43/3
HyponatraemiaMetabolism and nutrition disorders1/43/3
PainGeneral disorders3/40/3
AnaemiaBlood and lymphatic system disorders2/42/3
ConstipationGastrointestinal disorders2/42/3
NauseaGastrointestinal disorders2/40/3
Skin infectionInfections and infestations0/41/3
Aspartate aminotransferase increasedInvestigations0/41/3

Baseline characteristics

All treated and eligible patients

Age, Categorical
Age, Categorical(Participants)Arm IArm 2Total
<=18 years000
Between 18 and 65 years000
>=65 years437
Age, Continuous
Age, Continuous(years)Arm IArm 2Total
Mean74 ± 5.373 ± 4.974 ± 4.7
Sex: Female, Male
Sex: Female, Male(Participants)Arm IArm 2Total
Female101
Male336
08

Study locations

1 site
  • Roswell Park Cancer Institute
    Buffalo, New York 14263, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01108003
Lead sponsor
Roswell Park Cancer Institute
Collaborators
Johns Hopkins University, National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Apr 21, 2010
Start date
Apr 2010
Primary completion
Sep 2014
Completion
Oct 2015
Results posted
Jun 23, 2016
Last update
Jun 26, 2017

Study contacts

James Marshall, PhD
principal investigator · Roswell Park Cancer Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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