Risk of Fatigue in Adolescent and Young Adult Hodgkin Lymphoma Patients

Sponsor

Vanderbilt University (Other)

Overall Status

Completed

CT.gov ID

NCT01228461

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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:

Fatigue is more prevalent and severe among AYA HL patients and survivors, compared to general population and will be associated with impaired functional outcome.
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.
Risk of fatigue is associated with long-term cardiopulmonary and endocrine complications.
Levels of specified proinflammatory cytokines are associated with increased fatigue.

Condition or Disease	Intervention/Treatment	Phase
Fatigue Hodgkin Lymphoma

Study Design

Study Type:

Observational

Actual Enrollment :

10 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
AYA with Fatigue and Hodgkin Lymphoma

Outcome Measures

Primary Outcome Measures

Prevalence and severity of fatigue and its impact on functional outcomes [1 year]

Secondary Outcome Measures

Evaluate the association between levels of proinflammatory cytokine activity and fatigue [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 39 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

Vanderbilt University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vanderbilt University

ClinicalTrials.gov Identifier:

NCT01228461

Other Study ID Numbers:

091550

First Posted:

Oct 26, 2010

Last Update Posted:

Apr 4, 2017

Last Verified:

Mar 1, 2017

Keywords provided by Vanderbilt University

Hodgkin Lymphoma Survivors

Adolescent and Young Adults

Additional relevant MeSH terms:

Lymphoma

Hodgkin Disease

Fatigue

Study Results

No Results Posted as of Apr 4, 2017