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Risk of Fatigue in Adolescent and Young Adult Hodgkin Lymphoma Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vanderbilt University Medical Center ( Vanderbilt University )
ClinicalTrials.gov Identifier:
NCT01228461
First received: October 22, 2010
Last updated: March 30, 2017
Last verified: March 2017
October 22, 2010
March 30, 2017
February 2010
January 2012   (Final data collection date for primary outcome measure)
Prevalence and severity of fatigue and its impact on functional outcomes [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT01228461 on ClinicalTrials.gov Archive Site
Evaluate the association between levels of proinflammatory cytokine activity and fatigue [ Time Frame: 1 year ]
Same as current
Not Provided
Not Provided
 
Risk of Fatigue in Adolescent and Young Adult Hodgkin Lymphoma Patients
Not Provided

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples Without DNA
Description:
Serum samples for IL-1ra and CRP
Non-Probability Sample
Adolescents and young adult survivors of Hodgkin Lymphoma
  • Fatigue
  • Hodgkin Lymphoma
Not Provided
AYA with Fatigue and Hodgkin Lymphoma
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
January 2012
January 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Currently 18 years of age or older
  • Alive without evidence of recurrent disease
  • Must be off therapy (not on active treatment for HL or other malignancies)
  • Must not be on any form of chemotherapy (oral or intravenous [IV])
  • Provide informed consent
  • Can read and understand English
  • Treated with risk-adapted therapy which may include radiotherapy doses < 30 Gy

Exclusion Criteria:

  • Evidence of a subsequent malignancy following lymphoma treatment
Sexes Eligible for Study: All
15 Years to 39 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01228461
091550
No
Not Provided
Not Provided
Vanderbilt University Medical Center ( Vanderbilt University )
Vanderbilt University
Not Provided
Not Provided
Vanderbilt University Medical Center
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP