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
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.
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.
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 →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.
Exclusion Criteria:
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
Patients receive mango juice alone.
Other: Mango Juice
Given orally
Correlative studies
given orally
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
Apoptosis, Cell Proliferation, and Microvessel Density
Time frame: 1 year
| Milestone | Arm I | Arm 2 |
|---|---|---|
| Started | 4 | 3 |
| Completed | 4 | 3 |
| Not completed | 0 | 0 |
Number of participants with an adverse event.
| participants | Arm I | Arm 2 |
|---|---|---|
| Toxicity as Assessed by National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0 | 4 | 3 |
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I | — | 2/4 (50%) | 4/4 (100%) |
| Arm 2 | — | 1/3 (33.3%) | 3/3 (100%) |
| Event | Arm I | Arm 2 |
|---|---|---|
| SepsisInfections and infestations | 0/4 | 1/3 |
| FungaemiaInfections and infestations | 1/4 | 0/3 |
| UrosepsisInfections and infestations | 1/4 | 0/3 |
| Event | Arm I | Arm 2 |
|---|---|---|
| Lymphocyte count decreasedInvestigations | 2/4 | 3/3 |
| HyperglycaemiaMetabolism and nutrition disorders | 3/4 | 3/3 |
| HypocalcaemiaMetabolism and nutrition disorders | 1/4 | 3/3 |
| HyponatraemiaMetabolism and nutrition disorders | 1/4 | 3/3 |
| PainGeneral disorders | 3/4 | 0/3 |
| AnaemiaBlood and lymphatic system disorders | 2/4 | 2/3 |
| ConstipationGastrointestinal disorders | 2/4 | 2/3 |
| NauseaGastrointestinal disorders | 2/4 | 0/3 |
| Skin infectionInfections and infestations | 0/4 | 1/3 |
| Aspartate aminotransferase increasedInvestigations | 0/4 | 1/3 |
All treated and eligible patients
| Age, Categorical(Participants) | Arm I | Arm 2 | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 4 | 3 | 7 |
| Age, Continuous(years) | Arm I | Arm 2 | Total |
|---|---|---|---|
| Mean | 74 ± 5.3 | 73 ± 4.9 | 74 ± 4.7 |
| Sex: Female, Male(Participants) | Arm I | Arm 2 | Total |
|---|---|---|---|
| Female | 1 | 0 | 1 |
| Male | 3 | 3 | 6 |
This study is terminated, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Roswell Park Cancer Institute