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Risk of Fatigue in Adolescent and Young Adult Hodgkin Lymphoma Patients

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clinicaltrials.gov/study/NCT01228461
Is a
‌
Clinical study
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Clinical Study attributes

NCT Number
NCT012284610
Health Conditions in Trial
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Fatigue
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Trial Recruitment Size
100
Trial Sponsor
Vanderbilt University
Vanderbilt University
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Clinical Trial Start Date
2010
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Primary Completion Date
2012
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Study Completion Date
2012
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Clinical Trial Study Type
Observational0
Observational Clinical Trial Type
Cohort0
Observational Study Perspective
Retrospective0
Participating Facility
‌
Vanderbilt University Medical Center
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Last Updated
April 4, 2017
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Study summary

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. The 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: Primary 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 Secondary 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. Hypotheses: 1. Fatigue is more prevalent and severe among AYA HL patients and survivors, compared to general population and will be associated with impaired functional outcome. 2. 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. 3. Risk of fatigue is associated with long-term cardiopulmonary and endocrine complications. 4. Levels of specified proinflammatory cytokines are associated with increased fatigue.

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