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Trial record 3 of 179 for:    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

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Dietary Supplement: curcumin Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 30, 2007
Actual Primary Completion Date : August 5, 2015
Actual Study Completion Date : August 5, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Curcumin

Arm Intervention/treatment
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

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.
Dietary Supplement: Placebo



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Publications:
Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03211104     History of Changes
Other Study ID Numbers: 2007-06-068
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: July 7, 2017
Last Verified: May 2017

Keywords provided by Samsung Medical Center:
intermittent androgen deprivation therapy
curcumin

Additional relevant MeSH terms:
Curcumin
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action