Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2025-12-28 @ 1:06 PM
Study NCT ID:
NCT01228461
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2010-10-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk of Fatigue in Adolescent and Young Adult Hodgkin Lymphoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum samples for IL-1ra and CRP'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-30', 'studyFirstSubmitDate': '2010-10-22', 'studyFirstSubmitQcDate': '2010-10-25', 'lastUpdatePostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence and severity of fatigue and its impact on functional outcomes', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Evaluate the association between levels of proinflammatory cytokine activity and fatigue', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hodgkin Lymphoma Survivors', 'Adolescent and Young Adults'], 'conditions': ['Fatigue', 'Hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': 'Fatigue is one of the most prevalent symptoms endorsed by cancer survivors, particularly those treated for breast cancer or Hodgkin lymphoma. Despite the tremendous implications such work has for effective interventions, little is known about the underlying pathophysiology of fatigue, association with medical co-morbidities and factors that may help predict those to be at highest risk.\n\nThe proposed research will utilize Vanderbilt-Ingram Cancer Center REACH for Survivorship Program together with the investigators Hematologic Malignancies Program. In adolescent and young adults (AYA), ages 18 - 39 the investigators will address the following:\n\nPrimary Aims Aim 1: Assess the prevalence and severity of fatigue and its impact on functional outcomes Aim 2: Determine host, disease and treatment-related risk factors for fatigue\n\nSecondary Aims Aim 1: Evaluate the association between levels of proinflammatory cytokine activity and fatigue Aim 2: Evaluate the association between fatigue and self reported fatigue in AYA Hodgkin lymphoma (HL) survivors.\n\nHypotheses:\n\n1. Fatigue is more prevalent and severe among AYA HL patients and survivors, compared to general population and will be associated with impaired functional outcome.\n2. Risk factors for fatigue include higher disease stage, B symptoms and elevated erythrocyte sedimentation rate at diagnosis, dose density of chemotherapy and higher doses and more expanded fields of radiotherapy.\n3. Risk of fatigue is associated with long-term cardiopulmonary and endocrine complications.\n4. Levels of specified proinflammatory cytokines are associated with increased fatigue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '39 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adolescents and young adult survivors of Hodgkin Lymphoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently 18 years of age or older\n* Alive without evidence of recurrent disease\n* Must be off therapy (not on active treatment for HL or other malignancies)\n* Must not be on any form of chemotherapy (oral or intravenous \\[IV\\])\n* Provide informed consent\n* Can read and understand English\n* Treated with risk-adapted therapy which may include radiotherapy doses \\< 30 Gy\n\nExclusion Criteria:\n\n* Evidence of a subsequent malignancy following lymphoma treatment'}, 'identificationModule': {'nctId': 'NCT01228461', 'briefTitle': 'Risk of Fatigue in Adolescent and Young Adult Hodgkin Lymphoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'orgStudyIdInfo': {'id': '091550'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AYA with Fatigue and Hodgkin Lymphoma'}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}