Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2026-04-08 @ 3:27 PM
Study NCT ID:
NCT00559195
Status:
COMPLETED
Last Update Posted:
2011-05-16
First Post:
2007-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epoetin Beta in Treating Fatigue and Anemia in Patients Receiving Palliative Care for Malignant Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C103998', 'term': 'epoetin beta'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'primaryPurpose': 'SUPPORTIVE_CARE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'lastUpdateSubmitDate': '2011-05-13', 'studyFirstSubmitDate': '2007-11-15', 'studyFirstSubmitQcDate': '2007-11-15', 'lastUpdatePostDateStruct': {'date': '2011-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue'}, {'measure': 'Quality of life'}], 'secondaryOutcomes': [{'measure': 'Hemoglobin level'}]}, 'conditionsModule': {'keywords': ['unspecified adult solid tumor, protocol specific', 'anemia', 'fatigue'], 'conditions': ['Anemia', 'Fatigue', 'Unspecified Adult Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Epoetin beta may cause the body to make more red blood cells and may help relieve fatigue in patients with malignant solid tumors receiving palliative care.\n\nPURPOSE: This phase II trial is studying how well epoetin beta works in treating fatigue and anemia in patients receiving palliative care for malignant solid tumors.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Evaluate the impact of epoetin beta on fatigue and quality of life of patients receiving palliative care for malignant solid tumors.\n\nSecondary\n\n* Evaluate the impact of epoetin beta on hemoglobin level (increase \\> 2 g/dL).\n\nOUTLINE: Patients receive epoetin beta subcutaneously once a week for up to 3 months.\n\nFatigue, quality of life, and hemoglobin and reticulocyte levels are assessed every 4 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed malignant solid tumor\n\n * No hematologic malignancy\n* Hemoglobin \\< 10.5 g/dL (anemic)\n* Receiving palliative care only\n\nPATIENT CHARACTERISTICS:\n\n* Life expectancy \\> 6 months\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No chronic anemia requiring treatment (e.g., thalassemia or sickle cell disease)\n* No uncontrolled hypertension\n* No allergy to any drugs or components used in the study\n* Not a prisoner or under guardianship or trusteeship\n* No mental disability that impairs a clear understanding of the study requirements\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* More than 2 months since prior specific anticancer therapy (e.g., chemotherapy, hormonal therapy, targeted therapy, or immunotherapy)\n* More than 1 month since prior and no concurrent participation in another clinical trial'}, 'identificationModule': {'nctId': 'NCT00559195', 'briefTitle': 'Epoetin Beta in Treating Fatigue and Anemia in Patients Receiving Palliative Care for Malignant Solid Tumors', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase 2 Study Evaluating the Efficacy of Epoetin Beta (Neocormon®) For Fatigue and Quality of Life of Patients Receiving Palliative Care for a Solid Malignant Tumor', 'orgStudyIdInfo': {'id': 'CDR0000574173'}, 'secondaryIdInfos': [{'id': 'CHUL-NEOPALIA'}, {'id': 'RECF0359'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'epoetin beta', 'type': 'BIOLOGICAL'}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'Centre Hospital Regional Universitaire de Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}], 'overallOfficials': [{'name': 'Jean-Luc Labourey', 'role': 'STUDY_CHAIR', 'affiliation': 'Centre Hospital Regional Universitaire de Limoges'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospital Regional Universitaire de Limoges', 'class': 'OTHER'}}}}