Humoral and Cellular Immune Responses After Influenza Vaccination in Patients With Postcancer Fatigue and in Patients With Chronic Fatigue Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01651754|
Recruitment Status : Completed
First Posted : July 27, 2012
Last Update Posted : July 27, 2012
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 or disease||Intervention/treatment||Phase|
|Postcancer Fatigue Chronic Fatigue Syndrome||Biological: Seasonal influenza vaccination||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Humoral and Cellular Immune Responses After Influenza Vaccination in Patients With Postcancer Fatigue and in Patients With Chronic Fatigue Syndrome.|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||June 2012|
|Seasonal influenza vaccination||
Biological: Seasonal influenza vaccination
single dose of influenza vaccination
- 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) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651754
|University Medical Centre Nijmegen st Radboud|
|Principal Investigator:||H.W.M. van Laarhoven, Md||University Medical Centre Nijmegen st Radboud|