Humoral and Cellular Immune Responses After Influenza Vaccination in Patients With Postcancer Fatigue and in Patients With Chronic Fatigue Syndrome

NCT01651754 | Completed

• 1 other identifier: UMCNONCO201009
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postcancer Fatigue; Chronic Fatigue Syndrome

Outcome Measures

Primary Outcomes (1)

• Humoral and cellular immune responses after influenza vaccination in patients with postcancer fatigue and in patients with chronic fatigue syndrome.

  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.

  before vaccination, 1 and 3 weeks after vaccination (change in immune response from pre- to post-vaccination)

Study Arms (1)

Seasonal influenza vaccination

OTHER

Biological: Seasonal influenza vaccination

Interventions

Seasonal influenza vaccination BIOLOGICAL

single dose of influenza vaccination

Seasonal influenza vaccination

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 60 years old
• 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
• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

University Medical Centre Nijmegen st Radboud

Nijmegen, Netherlands

Location

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• H.W.M. van Laarhoven, Md

  University Medical Centre Nijmegen st Radboud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2012
• First Posted: July 27, 2012
• Study Start: September 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: June 1, 2012
• Last Updated: July 27, 2012

Record last verified: 2012-06

Locations

NL (1)