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Trial record 31 of 153 for:    Enzyme | curcumin

Comparison of Duration of Treatment Interruption With or Without Curcumin During the Off Treatment Periods in Patients With Prostate Cancer Undergoing Intermittent Androgen Deprivation Therapy

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ClinicalTrials.gov Identifier: NCT03211104
Recruitment Status : Completed
First Posted : July 7, 2017
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE May 9, 2017
First Posted Date  ICMJE July 7, 2017
Last Update Posted Date July 7, 2017
Actual Study Start Date  ICMJE August 30, 2007
Actual Primary Completion Date August 5, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2017)
Duration of treatment interruption with or without curcumin [ Time Frame: up to 42 months ]
To determine whether the period from the first interruption of the androgen deprivation therapy to the time when androgen deprivation therapy needs to be retreated differ between curcumin group and placebo group
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2017)
  • Mean change in PSA(ng/ml) from baseline between curcumin group versus placebo [ Time Frame: 0,1,2,3,4,5,6,12,18,30,42 months ]
    Measure the mean change of PSA at each point from the baseline and compare differences between the two groups
  • Mean change in testosterone(ng/ml) from baseline between curcumin group versus [ Time Frame: 0,1,2,3,4,5,6,12,18,30,42 months ]
    Measure the mean change of testosterone at each point from the baseline and compare differences between the two groups
  • Adverse events [ Time Frame: 0,1,2,3,4,5,6,12,18,30,42 months ]
    Adverse events were recorded according to the Common Terminology Criteria for Adverse Events(CTCAE). Vital sign, blood test and urine analysis were also performed.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Duration of Treatment Interruption With or Without Curcumin During the Off Treatment Periods in Patients With Prostate Cancer Undergoing Intermittent Androgen Deprivation Therapy
Official Title  ICMJE Comparison of Duration of Treatment Interruption With or Without Curcumin During the Off Treatment Periods in Patients With Prostate Cancer Undergoing Intermittent Androgen Deprivation Therapy : a Randomized, Double Blind, Placebo-controlled Trial
Brief Summary This was a placebo-controlled, double-blind, randomized trial designed with the aim of establishing whether curcumin influenced the duration of treatment interruption and rate of prostatic specific antigen(PSA) progression, compared with placebo among men with prostate cancer receiving intermittent androgen deprivation therapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Dietary Supplement: curcumin
  • Dietary Supplement: Placebo
Study Arms  ICMJE
  • Experimental: curcumin

    Curcumin extracted from curcuma longa linn.

    • formulation : curcumin powder 240mg/capsule
    • general name : Diferuloylmethane

    Taking curcumin 3 times a day(1,440mg/day) for 6 months at the first off treatment in patients with prostate cancer receiving intermittent androgen deprivation therapy

    Intervention: Dietary Supplement: curcumin
  • Placebo Comparator: control
    The control group Take a placebo containing lactose and vitamin B2. Reddish brown capsules with the same shape as curcumin.
    Intervention: Dietary Supplement: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 5, 2017)
107
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 5, 2015
Actual Primary Completion Date August 5, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients diagnosed with prostate cancer in biopsy
  • among patients with biochemical recurrence after treatment(radical prostatectomy, radiation therapy, focal therapy, etc.) for localized prostate cancer or metastatic prostate cancer at the time of diagnosis, who received intermittent androgen deprivation therapy(IAD)
  • patients who off-treatment for the first time by receiving androgen deprivation therapy(ADT) for more than 6 months and PSA nadir remained stable for more than 3 months

Exclusion Criteria:

  • previous history of IAD
  • patient with other serious or ongoing medical or psychiatric disease other than prostate cancer
  • hypersensitivity or suspicious of curcumin
  • history of taking health supplements containing curcumin for prostate cancer treatment before 6 months of clinical trial participation
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03211104
Other Study ID Numbers  ICMJE 2007-06-068
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Samsung Medical Center
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP