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CAPSAICIN Trial: Assessing Capsaicin as a Chemopreventive Agent for Prostate Cancer (CAPSAICIN)

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ClinicalTrials.gov Identifier: NCT02037464
Recruitment Status : Unknown
Verified January 2014 by Dr. Laurence Klotz, Sunnybrook Health Sciences Centre.
Recruitment status was:  Not yet recruiting
First Posted : January 16, 2014
Last Update Posted : January 16, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Laurence Klotz, Sunnybrook Health Sciences Centre

Brief Summary:
The purpose of this study is to determine the chemopreventive properties of capsaicin, the active compound in chili peppers, in prostate cancer patients enrolled in the active surveillance program or patients scheduled to undergo radical prostatectomy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Dietary Supplement: Capsaicin Supplement (Cayenne by Nature's Way) Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: CAPSAICIN Trial: A Prospective Study of Capsaicin in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance or Radical Prostatectomy
Study Start Date : January 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

Arm Intervention/treatment
Experimental: Capsaicin Supplement Dietary Supplement: Capsaicin Supplement (Cayenne by Nature's Way)
One capsule of the supplement to be taken twice daily.
Other Name: Naturesway Cayenne 40,000 H.U. (NPN #80013036)




Primary Outcome Measures :
  1. Biomarker Changes [ Time Frame: 6-8 weeks or 9 +/-3 months ]
    Determine effect of capsaicin therapy on expression of ki67 and p27 biomarkers in a post-treatment biopsy.


Secondary Outcome Measures :
  1. PSA Kinetics [ Time Frame: 1 year ]
  2. Tumor grade [ Time Frame: 1 year ]
  3. Biomarkers [ Time Frame: 1 year ]
    To assess the effect of capsaicin therapy on the expression of markers of apoptosis, cell cycle, TRP-V1 and TRP-V6



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is >19 years of age
  2. Subject has a histologically documented diagnosis of prostate adenocarcinoma
  3. Being monitored by active surveillance (see Table 1) for favourable risk prostate cancer as defined by the following:

    1. Clinical stage T1b, T1c, T2a or T2b at the time of diagnosis
    2. Clinical (diagnostic biopsy) Gleason score < 6
    3. PSA < 10.0 ng/ml (ug/L)
  4. Tumour material from most recent prostate biopsy available with sample (up to 10 unstained slides) collected for determination of ki67 and p27 biomarker expression.
  5. Scheduled to have an active surveillance mandated transrectal ultrasound (TRUS) guided biopsy within 6 - 12 months of Day 1 of the study

Exclusion Criteria:

  1. Previous malignancy (not including curatively treated basal or squamous cell carcinoma of the skin) within the previous 5 years. (Ta bladder cancer with negative surveillance cystoscopy within the past 2 years may be included.)
  2. No previous or current treatment (medical therapy or radical intervention) for prostate cancer excluding biopsy
  3. Inability to undergo TRUS biopsy
  4. Concurrent administration of the following medications is not permitted during the protocol:

    • 5 α-reductase inhibitors
    • Cytotoxic chemotherapy
    • Immunotherapy
    • Hormonal therapy (megestrol, medroxyprogesterone, cyproterone, diethylstilbestrol, hyrodcortisone, etc.)
    • Non-steroidal anti-androgens (bicalutamide, nilutamide, flutamide, etc.)
    • Luteinizing hormone releasing Hormone (LHRH) analogues (leuprolide, goserelin, etc.)
    • Ketoconazole
    • PC-SPES and any other preparations thought to have endocrine effects
    • Medications which inhibit cholesterogenesis ('statin' medications, etc.)
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status > 2
  6. Known or history of liver disease (total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 upper limit of normal at screening visit)
  7. Subject has a minimum life expectancy of < 5 years
  8. Subject is unable to give written and informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02037464


Contacts
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Contact: Marlene Kebabdjian 416-480-6100 Marlene.Kebabdjian@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Hospital Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Marlene Kebabdjian       marlene.kebabdjian@sunnybrook.ca   
Principal Investigator: Laurence Klotz, MD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: Laurence Klotz, MD Sunnybrook Hospital

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Responsible Party: Dr. Laurence Klotz, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02037464     History of Changes
Other Study ID Numbers: 264-2013
First Posted: January 16, 2014    Key Record Dates
Last Update Posted: January 16, 2014
Last Verified: January 2014
Keywords provided by Dr. Laurence Klotz, Sunnybrook Health Sciences Centre:
Prostate Cancer
Active Surveillance
Radical Prostatectomy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs