Humoral and Cellular Immune Responses After Influenza Vaccination in Patients With Postcancer Fatigue and in Patients With Chronic Fatigue Syndrome
This study has been completed.
Sponsor:
Radboud University
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01651754
First received: June 21, 2012
Last updated: July 26, 2012
Last verified: June 2012
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Purpose
Postcancer fatigue (PCF) is a frequently occurring, severe and invalidating problem, impairing quality of life. Patients with chronic fatigue syndrome (CFS) also suffer from severe fatigue symptoms. Although it is possible to effectively treat CFS, the nature of the underlying physiology remains unclear. The presence of an underlying immunological problem has been suggested as an explanation for PCF and CFS. The aim of this study is to compare the humoral and cellular immune responses upon influenza vaccination in PCF patients, CFS patients, non-fatigued cancer survivors, and healthy controls.
PCF (n=20) and CFS patients (n=20) will be vaccinated against influenza. Age and gender matched non-fatigued cancer survivors (n=20) and healthy controls (n=20) will be included for comparison. Antibody responses will be measured at baseline and at day 21 by a hemagglutination inhibition test. T cell responses will be measured at baseline and at day 7 by lymphocyte proliferation, activation, and cytokine secretion.
| Condition | Intervention |
|---|---|
|
Postcancer Fatigue Chronic Fatigue Syndrome |
Biological: Seasonal influenza vaccination |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Humoral and Cellular Immune Responses After Influenza Vaccination in Patients With Postcancer Fatigue and in Patients With Chronic Fatigue Syndrome. |
Resource links provided by NLM:
Further study details as provided by Radboud University:
Primary Outcome Measures:
- Humoral and cellular immune responses after influenza vaccination in patients with postcancer fatigue and in patients with chronic fatigue syndrome. [ Time Frame: before vaccination, 1 and 3 weeks after vaccination (change in immune response from pre- to post-vaccination) ] [ Designated as safety issue: No ]Humoral and cellular immune responses after influenza vaccination in patients with postcancer fatigue and in patients with chronic fatigue syndrome. The humoral immune responses will be measured by the hemagglutination-inhibition antibody test. The cellular immune responses will be measured by T lymphocyte proliferation and cytokine secretion of peripheral blood mononuclear cells. A full blood cell count will be performed and hemoglobin, glucose, and cholesterol levels, iron status, electrolyte balance, erythrocyte sedimentation rate, and thyroid, kidney, and liver function will be checked.
| Enrollment: | 72 |
| Study Start Date: | September 2010 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Seasonal influenza vaccination |
Biological: Seasonal influenza vaccination
single dose of influenza vaccination
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- General inclusion criteria
- Age between 18 and 60 years old
- Written informed consent Inclusion criteria cancer survivors
- Severely fatigued (CIS-fatigue score ≥ 35) or non-fatigued (CIS-fatigue < 27)
- Treated for a malignant, solid tumor
- Completion of treatment for cancer minimal 1 year ago
- Disease-free, as defined by the absence of somatic disease activity parameters
- Age at disease onset minimal 18 years Inclusion criteria CFS patients
- Severe, persistent or continuously returning complaints of fatigue, which do not improve noteworthy after rest and which are not the consequence of continuous exertion
- The fatigue resulted into a substantial decrease in former levels of professional, social and/or personal functioning
- The complaints cannot be explained by a physical cause
- The complaints persist for at least 6 months
Exclusion Criteria:
- - Psychological or psychiatric treatment
- Physical comorbidity that could explain the fatigue
- Treatment with anti-depressive drugs, anti-epileptic drugs, or benzodiazepines
- A known immune deficiency
- Treatment with corticosteroids during the last 2 weeks
- Symptoms of influenza
- Allergy for chicken protein
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01651754
Locations
| Netherlands | |
| University Medical Centre Nijmegen st Radboud | |
| Nijmegen, Netherlands | |
Sponsors and Collaborators
Radboud University
Investigators
| Principal Investigator: | H.W.M. van Laarhoven, Md | University Medical Centre Nijmegen st Radboud |
More Information
No publications provided
| Responsible Party: | Radboud University |
| ClinicalTrials.gov Identifier: | NCT01651754 History of Changes |
| Other Study ID Numbers: | UMCNONCO201009 |
| Study First Received: | June 21, 2012 |
| Last Updated: | July 26, 2012 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Additional relevant MeSH terms:
|
Fatigue Fatigue Syndrome, Chronic Influenza, Human Signs and Symptoms Virus Diseases Muscular Diseases Musculoskeletal Diseases Encephalomyelitis |
Central Nervous System Diseases Nervous System Diseases Neuromuscular Diseases Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013