Clinical trial NCT01228461: Risk of Fatigue in Adolescent and Young Adult Hodgkin Lymphoma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fatigue
Hodgkin Lymphoma
Keywords: Hodgkin Lymphoma Survivors
Adolescent and Young Adults
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2010-10-26
Enrollment: 10
Sex: ALL
Minimum age (years): 15
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents and young adult survivors of Hodgkin Lymphoma

Brief 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.


Eligibility 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

Primary outcomes:
measure: Prevalence and severity of fatigue and its impact on functional outcomes
timeFrame: 1 year
Secondary outcomes:
measure: Evaluate the association between levels of proinflammatory cytokine activity and fatigue
timeFrame: 1 year
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References: