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OpenTrials
Completed

NCT Number: NCT01228461

Risk of Fatigue in Adolescent and Young Adult Hodgkin Lymphoma Patients

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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Key information

Age range

15 year–39 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence and severity of fatigue and its impact on functional outcomes

    Time frame: 1 year

Secondary outcomes

  1. Evaluate the association between levels of proinflammatory cytokine activity and fatigue

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 26, 2010
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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