Risk of Fatigue in Adolescent and Young Adult Hodgkin Lymphoma Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01228461

Enrollment

Registered

2010-10-26

Start date

2010-02-28

Completion date

2012-01-31

Last updated

2017-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue, Hodgkin Lymphoma

Keywords

Hodgkin Lymphoma Survivors, Adolescent and Young Adults

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

15 Years to 39 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Prevalence and severity of fatigue and its impact on functional outcomes	1 year

Secondary

Measure	Time frame
Evaluate the association between levels of proinflammatory cytokine activity and fatigue	1 year

Countries

United States

Outcome results