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About
This study will test whether oral intake of a dietary supplement called BroccoMax®, which is a special blend of broccoli extract containing a chemical called sulforaphane (hereafter abbreviated as SFN), may result in changes in chemicals that feed prostate cancer. BroccoMax® is available over the counter.
Full description
Eligible subjects will be randomly assigned to either BroccoMax® or placebo arm with a 1:1 randomization. Each subject will be given BroccoMax® equivalent to 4 weeks supply. Following randomization, subjects will begin to take four study tablets (BroccoMax® or placebo) in the morning with breakfast and four tablets in the evening with dinner. The eight BroccoMax® tablets will provide a daily internal dose of 64 mg of SFN.
Baseline evaluation will be 28 days before scheduled prostatectomy, the same day of study drug dispensation, and will include.
Day 28 ± 3 days (End of study evaluation)
Post-Treatment Follow-Up All study participants will have routine follow-up as determined by their treating urologist and/ or medical oncologist. This usually occurs 6 ± 2 weeks post-surgery and every 3 months thereafter. These are considered standard of care visits. The patient chart will be reviewed for their history and physical findings at these visits.
Enrollment
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Volunteers
Inclusion criteria
Men ≥ 18 years of age scheduled to undergo radical prostatectomy as standard of care for a diagnosis of prostate adenocarcinoma.
Subjects willing to take oral placebo or BroccoMax® pills (4 capsules twice daily after breakfast and dinner) on a daily basis for 4 weeks prior to prostatectomy. Subjects have the ability to swallow BroccoMax® or placebo pills.
Subjects in good health per investigator evaluation with liver enzyme and blood count values within the following ranges:
White blood cells ≥ 3,000/mL Total bilirubin ≤ 1.5 x Upper Limits of Normal (ULN) Aspartate Aminotransferase (AST (SGOT))/ Alanine Aminotransferase (ALT (SGPT)) ≤ 2.5 x ULN Blood Urea Nitrogen (BUN) and serum creatinine ≤ 1.5 x ULN
Subjects willing to abstain from dietary sources of glucosinolates and isothiocyanates (see Appendix) for the duration of the study (4 weeks)
Subjects must be fully informed of the investigational nature of this study and must sign a written informed consent in accordance within institutional and regulatory guidelines
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
39 participants in 2 patient groups, including a placebo group
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Central trial contact
Dawn McBride, RN
Data sourced from clinicaltrials.gov
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