Clinical Trial: Cytokine Inhibition in Chronic Fatigue Syndrome Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Cytokine Inhibition in Chronic Fatigue Syndrome Patients

Brief Summary:

Rationale: Chronic fatigue syndrome (CFS) is a medically unexplained syndrome for which no somatic or pharmacological treatment has been proven effective. Dysfunction of the cytokine network has been suspected to play a role in the pathophysiology of CFS. Although derangements of the cytokine network in CFS are controversial, a major problem is that many studies did not use adequate controls. In addition, all studies have been performed on peripheral venous blood of the patients. As cytokines mainly act in the tissues, e.g., the brain, the information that can be derived from peripheral blood cells is limited. The only information regarding the possible role of cytokines in the pathophysiology of CFS could come from intervention studies in which pathogenetically important cytokines are inhibited. A potentially relevant cytokine which can be blocked in humans without severe side effects is IL-1. Although it is plausible that these cytokines play a role in CFS, there is limited evidence for this.

Objective: To investigate the effect on symptomatology of interference with IL-1 in CFS patients.

Study design: A randomized placebo controlled study will be performed to determine whether interference with IL-1 is able to reduce fatigue and disabilities in CFS patients.

Study population: Female CFS patients without psychiatric co-morbidity will be included in this study. Patients of the outpatient clinic of the Department of General internal medicine and the Expert Centre for Chronic Fatigue (ECCF) will be asked to participate in the study. Patients will be asked to bring a healthy neighbourhood control to their first study visit.

Intervention: After inclusion patients will be randomized to receive one of the following treatments:

Detailed Summary:
Sponsor: Radboud University

Current Primary Outcome: CIS (checklist individual strength, compared to baseline) [ Time Frame: 4 weeks, measurement will be repeated up to 26 weeks ]

To investigate the role of the cytokine IL-1 in the pathogenesis of CFS and to find leads for future treatment of CFS, a disorder for which there is no proven effective drug treatment. The primary outcome measure will be fatigue severity at 4 weeks measured with the Checklist Individual Strength (CIS).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • SIP8 (sickness impact profile, change from baseline) [ Time Frame: 4 weeks, measurement will be repeated up to 26 weeks ]
    level of functional impairment
  • SF-36 (subscale physical functioning and social functioning, compared to baseline) [ Time Frame: 4 weeks, measurement will be repeated up to 26 weeks ]
    physical and social functioning assessed with the subscale physical functioning and social functioning of the SF-36
  • SCL-90 (symptom checklist-90, compared to baseline) [ Time Frame: 4 weeks, measurement will be repeated up to 26 weeks ]
    level of psychological distress assessed with the total score on the Symptom Checklist-90
  • VAS pain (visual analog scale, compared to baseline) [ Time Frame: 4 weeks, measurement will be repeated up to 26 weeks ]
    pain severity assessed with a Visual Analog Scale
  • Cortisol in saliva and hair (concentration compared to baseline) [ Time Frame: 4 weeks ]
    Because of the possible role of the hypothalamus-pituitary-adrenal axis we will also measure the cortisol concentration in saliva and hair. For the baseline assessment, comparison will be made with matched neighbourhood controls.
  • microbiome determination faeces [ Time Frame: at baseline ]
    A new field of great interest in pathophysiology is the role of the microbial flora of the host (microbiome). The availability of well defined patients with CFS and matched controls is a great opportunity in an unexplored area of CFS research, to assess whether the microbiome of CFS patients is peculiar.
  • cytokine concentrations in blood and saliva (compared to baseline) [ Time Frame: 4 weeks ]
    In addition to the cytokine intervention, we will assess cytokines (at the transcriptional level and as proteins) in serum and saliva at baseline and after 4 weeks of intervention. For the baseline assessment, comparison will be made with matched neighbourhood controls.


Original Secondary Outcome: Same as current

Information By: Radboud University

Dates:
Date Received: March 21, 2014
Date Started: June 2014
Date Completion:
Last Updated: May 24, 2016
Last Verified: April 2016