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:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Syndrome
Fatigue Syndrome, Chronic
Signs and Symptoms
Disease
Pathologic Processes
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on October 01, 2014