Risk of Fatigue in Adolescent and Young Adult Hodgkin Lymphoma Patients

Fatigue Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01228461
• Other study ID #: 091550
• Status: Completed
• Phase: N/A
• First received: October 22, 2010
• Last updated: March 30, 2017
• Start date: February 2010
• Est. completion date: January 2012

Study information

• Verified date: March 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence and severity of fatigue and its impact on functional outcomes		1 year
Secondary	Evaluate the association between levels of proinflammatory cytokine activity and fatigue		1 year