Risk of Fatigue in Adolescent and Young Adult Hodgkin Lymphoma Patients

NCT01228461 | Completed

• 1 other identifier: 091550
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.Risk of fatigue is associated with long-term cardiopulmonary and endocrine complications.
4. 4.Levels of specified proinflammatory cytokines are associated with increased fatigue.

Conditions

Fatigue; Hodgkin Lymphoma

Keywords

Hodgkin Lymphoma Survivors; Adolescent and Young Adults

Outcome Measures

Primary Outcomes (1)

• Prevalence and severity of fatigue and its impact on functional outcomes

  1 year

Secondary Outcomes (1)

• Evaluate the association between levels of proinflammatory cytokine activity and fatigue

  1 year

Study Arms (1)

AYA with Fatigue and Hodgkin Lymphoma

Eligibility Criteria

• Age: 15 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents and young adult survivors of Hodgkin Lymphoma

You may qualify if:

• 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

You may not qualify if:

• Evidence of a subsequent malignancy following lymphoma treatment

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples for IL-1ra and CRP

MeSH Terms

Conditions

Fatigue; Hodgkin Disease

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2010
• First Posted: October 26, 2010
• Study Start: February 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: April 4, 2017

Record last verified: 2017-03

Locations

US (1)