Risk of Fatigue in Adolescent and Young Adult Hodgkin Lymphoma Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Vanderbilt University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01228461
First received: October 22, 2010
Last updated: November 11, 2010
Last verified: October 2010
  Purpose

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.

Condition
Fatigue
Hodgkin Lymphoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Prevalence and severity of fatigue and its impact on functional outcomes [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the association between levels of proinflammatory cytokine activity and fatigue [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum samples for IL-1ra and CRP


Estimated Enrollment: 40
Study Start Date: February 2010
Estimated Study Completion Date: February 2011
Groups/Cohorts
AYA with Fatigue and Hodgkin Lymphoma

  Eligibility

Ages Eligible for Study:   15 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adolescents and young adult survivors of Hodgkin Lymphoma

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01228461

Contacts
Contact: Pinki K Prasad, MD, MPH 615-322-0964 pinki.prasad@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Pinki K Prasad, MD, MPH    615-322-0964    pinki.prasad@vanderbilt.edu   
Contact: Jada Meriwether, BA    615-936-0413    jada.meriwether@vanderbilt.edu   
Principal Investigator: Pinki K Prasad, MD, MPH         
Sponsors and Collaborators
Vanderbilt University
  More Information

No publications provided

Responsible Party: Pinki K. Prasad, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01228461     History of Changes
Other Study ID Numbers: 091550
Study First Received: October 22, 2010
Last Updated: November 11, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Hodgkin Lymphoma Survivors
Adolescent and Young Adults

Additional relevant MeSH terms:
Fatigue
Hodgkin Disease
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014