Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-05 @ 10:51 AM
Study NCT ID:
NCT02724618
Status:
UNKNOWN
Last Update Posted:
2017-10-12
First Post:
2016-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nanocurcumin for Prostate Cancer Patients Undergoing Radiotherapy (RT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003474', 'term': 'Curcumin'}], 'ancestors': [{'id': 'D036381', 'term': 'Diarylheptanoids'}, {'id': 'D006536', 'term': 'Heptanes'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-11', 'studyFirstSubmitDate': '2016-03-09', 'studyFirstSubmitQcDate': '2016-03-30', 'lastUpdatePostDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proctitis [assessed using Common terminology criteria for adverse events (CTCAE)]', 'timeFrame': '90 days', 'description': 'Proctitis as assessed using Common terminology criteria for adverse events (CTCAE)'}], 'secondaryOutcomes': [{'measure': 'Cystitis [assessed using CTCAE Grading Criteria]', 'timeFrame': '90 days', 'description': 'Cystitis as assessed using CTCAE Grading Criteria'}, {'measure': 'Hematologic Toxicity', 'timeFrame': '90 days', 'description': 'Hematologic Toxicity as assessed by significant reduction in hematologic components'}, {'measure': 'Biochemical progression-free survival (b-PFS)', 'timeFrame': '5-years', 'description': 'b-PFS as assessed using Prostate-Specific Antigen (PSA)'}, {'measure': 'Treatment Response', 'timeFrame': '3 months after treatment termination', 'description': 'Treatment Response as assessed using Magnetic Resonance Imaging techniques'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Curcumin', 'Protection, Radiation', 'Controlled Clinical Trials, Randomized', 'Radiation Therapy', 'Prostate Cancer'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'There is a growing body of evidence exploring the role of curcumin as a radioprotector against radiation-induced injury in normal tissues as well as a radiosensitizer in tumor cells. The aim of this study is to determine the efficacy of oral nanocurcumin in prostate cancer patients undergoing radiotherapy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the prostate\n* Candidate for External Beam Radiotherapy\n* ECOG performance status 0-2\n\nExclusion Criteria:\n\n* Patients with Metastatic Prostate Cancer\n* Patients with Kidney \\& Liver dysfunction\n* Gastrointestinal disorders such as IBD, reflux and peptic ulcers\n* Any adverse reaction to curcumin'}, 'identificationModule': {'nctId': 'NCT02724618', 'briefTitle': 'Nanocurcumin for Prostate Cancer Patients Undergoing Radiotherapy (RT)', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': 'Phase II Study of Nanocurcumin Versus Placebo for Patients Undergoing Radiotherapy for Prostate Cancer', 'orgStudyIdInfo': {'id': '406'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Curcumin plus RT', 'description': '120mg/day nanocurcumin during RT course', 'interventionNames': ['Drug: Curcumin', 'Radiation: RT']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo plus RT', 'description': '120mg/day placebo of nanocurcumin during RT course', 'interventionNames': ['Radiation: RT', 'Drug: Placebo']}], 'interventions': [{'name': 'Curcumin', 'type': 'DRUG', 'otherNames': ['SinaCurcumin®'], 'description': '120mg/d oral nanocurcumin (3 capsules of SinaCurcumin®40 per day) 3 days before and during radiotherapy', 'armGroupLabels': ['Curcumin plus RT']}, {'name': 'RT', 'type': 'RADIATION', 'otherNames': ['External Beam Radiation Therapy (EBRT)'], 'description': 'EBRT is delivered as Intensity-Modulated Radiation Therapy (IMRT) or 3D-conformal RT', 'armGroupLabels': ['Curcumin plus RT', 'Placebo plus RT']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['SinaCurcumin® placebo'], 'description': 'Placebo (3 placebo capsules of SinaCurcumin®40 per day), 3 days before and during radiotherapy', 'armGroupLabels': ['Placebo plus RT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'facility': 'Shohada-e-Tajrish Medical Center', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Abolfazl Razzaghdoust', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shahid Beheshti University of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Behnam Daheshpour Charity Organization, Tehran, Iran', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Bahram Mofid', 'investigatorAffiliation': 'Shahid Beheshti University of Medical Sciences'}}}}