Risk of Fatigue in Adolescent and Young Adult Hodgkin Lymphoma Patients
Recruitment status was Recruiting
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Purpose
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 |
|---|
|
Fatigue Hodgkin Lymphoma |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
- Prevalence and severity of fatigue and its impact on functional outcomes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Evaluate the association between levels of proinflammatory cytokine activity and fatigue [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Serum samples for IL-1ra and CRP
| Estimated Enrollment: | 40 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | February 2011 |
| Groups/Cohorts |
|---|
| AYA with Fatigue and Hodgkin Lymphoma |
Eligibility| Ages Eligible for Study: | 15 Years to 39 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Adolescents and young adult survivors of Hodgkin Lymphoma
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| Contact: Pinki K Prasad, MD, MPH | 615-322-0964 | pinki.prasad@vanderbilt.edu |
| United States, Tennessee | |
| Vanderbilt University Medical Center | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Pinki K Prasad, MD, MPH 615-322-0964 pinki.prasad@vanderbilt.edu | |
| Contact: Jada Meriwether, BA 615-936-0413 jada.meriwether@vanderbilt.edu | |
| Principal Investigator: Pinki K Prasad, MD, MPH | |
More Information
No publications provided
| Responsible Party: | Pinki K. Prasad, Vanderbilt University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01228461 History of Changes |
| Other Study ID Numbers: | 091550 |
| Study First Received: | October 22, 2010 |
| Last Updated: | November 11, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Vanderbilt University:
|
Hodgkin Lymphoma Survivors Adolescent and Young Adults |
Additional relevant MeSH terms:
|
Fatigue Hodgkin Disease Lymphoma Signs and Symptoms Neoplasms by Histologic Type |
Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013