Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-29 @ 3:42 PM
Study NCT ID:
NCT02039635
Status:
COMPLETED
Last Update Posted:
2017-08-11
First Post:
2013-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Korean Red Ginseng in Treating Patients With Fatigue Caused by Chemotherapy for Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000713447', 'term': 'Asian ginseng'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 438}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-09', 'studyFirstSubmitDate': '2013-12-16', 'studyFirstSubmitQcDate': '2014-01-15', 'lastUpdatePostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Tumor response after 8 and 16 weeks of trial drug intake', 'timeFrame': 'Baseline, 8 and 16 weeks'}, {'measure': 'Progressive-free survival (PFS)', 'timeFrame': 'up to 16 weeks'}, {'measure': 'Change in blood cytokine(IL-2, IL-8, IL-10) level after 16 weeks of trial drug intake', 'timeFrame': 'Baseline, 16 weeks'}], 'primaryOutcomes': [{'measure': 'Area Under Curve (AUC) of Brief Fatigue Index (BFI) on the intake trial drugs up to 16 weeks', 'timeFrame': 'From Baseline up to 16 weeks'}], 'secondaryOutcomes': [{'measure': 'Area Under Curve (AUC) of Brief Fatigue Index (BFI) on the intake of trial drugs up to 8 weeks', 'timeFrame': 'From Baseline up to 8 weeks'}, {'measure': 'Change in Functional Assessment of Chronic Illness Therapy-Fatigue Trial Outcome Index (FACIT-F TOI) after 8 and 16 weeks of trial drug intake', 'timeFrame': 'Baseline, 8 and 16 weeks'}, {'measure': 'Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) total score after 8 and 16 weeks of trial drug in take', 'timeFrame': 'Baseline, 8 and 16 weeks'}, {'measure': 'The percentage of subjects whom the Functional Assessment of Cancer Therapy-General (FACT-G) score decreased more than 20 scores after 8 and 16 weeks of trial drug intake', 'timeFrame': 'Baseline, 8 and 16 weeks'}, {'measure': 'Change in blood cytokine (IL-1, IL-6, TNF-alpha) level after 16 weeks of trial drug intake', 'timeFrame': 'Baseline, 16 weeks'}, {'measure': 'Change in blood cortisol level after 16 weeks of trial drug intake', 'timeFrame': 'Baseline, 16 weeks'}, {'measure': 'Perceived Stress Scale (PSS) change after 16 weeks of trial drug intake', 'timeFrame': 'Baseline, 16 weeks'}, {'measure': 'adverse events', 'timeFrame': 'Baseline, 8 and 16 weeks', 'description': '* Voluntary reports of adverse events and collected reports of adverse events (agitation, anxiety, headache, insomnia, vomiting)\n* Laboratory and physical test\n* ECOG performance\n* ECG'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cancer', 'cancer related fatigue', 'Korean red ginseng', 'chemotherapy'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'Korean Red Ginseng may improve fatigue in healthy subject. It is not yet known whether Korean Red Ginseng is effective compared with a placebo in chemotherapy.\n\nThe purpose of this study is to determine whether Korean Red Ginseng is effective in the treatment of the fatigue from colorectal cancer with chemotherapy.(modified FOLFOX-6)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20 years and older\n* Person who agreed to participate in this study and signed voluntarily on the written informed consent form\n* Person who is confirmed as colorectal cancer through histological and image diagnosis and scheduled for adjuvant or palliative therapy with mFOLFOX-6 regimen\n* Fertile patients with negative pregnancy test confirmed and who has agreed to use effective contraception\n* Person who is able to fully communicate with the physician about his/her fatigue status and is able to completely fill out the questionnaires\n* Life expectancy more than 6 months\n* Performance status of ECOG grade 0\\~1\n* Hb ≥ 9g/dL\n* Person with moderate liver function (AST, ALT ≤ 2.5 × ULN)\n* Person with moderate renal function (Cr ≤ 1.5 × ULN)\n\nExclusion Criteria:\n\n* Pregnant or nursing women\n* Primary brain cancer, brain metastases or other CNS malignancy, including CNS lymphoma\n* No controlled pain despite the use if analgesics.\n* Person showing hypothyroidism despite the hormone treatment\n* Person with insomnia despite an appropriate treatment\n* No controlled hypertension (DBP \\>100mmHg or SBP \\>160mmHg)\n* Person who has experience of hypersensitivity to the trial drug (ginseng) components\n* Person with autoimmune disorders (Multiple sclerosis, Lupus, rheumarthritis etc.)\n* Person who is alcoholic dependent or has psychiatric disorder\n* Person who has cognitive or psychiatric problems\n* Person who has an experience of chemotherapy agents use 6 months before a screening visit\n* Person who had a surgery 2 weeks before a screening visit\n* Person who had taken herbal medicinal product (including Chinese medicine) 4 weeks before the screening visit\n* Person who has medical status that is judged to affect the result or who is judged as inappropriate for the study by the physician'}, 'identificationModule': {'nctId': 'NCT02039635', 'acronym': 'KRG', 'briefTitle': 'Korean Red Ginseng in Treating Patients With Fatigue Caused by Chemotherapy for Colorectal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Korea Ginseng Corporation'}, 'officialTitle': 'A Study of Korean Red Ginseng for Evaluation of Improvement of Cancer-related Fatigue in Patients With Colorectal Cancer With Chemotherapy: A Randomized, Double-blind, Placebo-Controlled, Parallel, Multicenter Trial', 'orgStudyIdInfo': {'id': 'KGC-S-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Korean Red Ginseng', 'description': 'Patients receive oral Korean Red Ginseng twice daily for 16 weeks. Treatment repeats every 4 weeks for 4 courses.\n\nIntervention: Dietary Supplement: Korean Red Ginseng', 'interventionNames': ['Dietary Supplement: Korean Red Ginseng']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients receive oral placebo twice daily for 16 weeks. Treatment repeats every 4 weeks for 4 courses.\n\nIntervention: Other: Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Korean Red Ginseng', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Given Orally', 'armGroupLabels': ['Korean Red Ginseng']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Given Orally', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '305-805', 'city': 'Shinseongdong', 'state': 'Daejeon', 'country': 'South Korea', 'facility': 'Korea Ginseng Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea Ginseng Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}