Humoral and Cellular Immune Responses After Influenza Vaccination in Patients With Postcancer Fatigue and in Patients With Chronic Fatigue Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Humoral and cellular immune responses after influenza vaccination in patients with postcancer fatigue and in patients with chronic fatigue syndrome.
研究概览
简要总结
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.
详细描述
Background PCF is a frequently occurring, severe, and invalidating problem in cancer survivors, impairing quality of life. The prevalence of PCF observed in longitudinal follow-up studies ranged from 19-39%. Cognitive behavior therapy, especially designed for PCF, seemed to be an effective treatment option for PCF. However, although it is now possible to effectively treat PCF, the nature of the underlying physiology of PCF remains unclear.
Hypotheses about mechanisms explaining cancer-related fatigue have already been described, including dysregulation of brain serotonin, dysregulation of the hypothalamic-pituitary-adrenal axis responsiveness, disruption of the circadian rhythm, alterations in muscle and ATP metabolism, and activation of the vagal afferent nerve. Furthermore, the presence of an underlying immunological problem has been suggested as an explanation for PCF.
Another group of patients suffering from severe fatigue symptoms are patients with CFS. The estimated worldwide prevalence of CFS is 0.4-1%. In the Netherlands, about 100.000 patients are suffering from chronic fatigue, of which 30.000 to 40.000 suffer from CFS. In contrast to fatigue in patients with PCF, in patients with CFS no clear precipitating factor could be identified. Also for patients with CFS, a cognitive behavior therapy is designed, which is proven to be effective, but the pathophysiological mechanism of CFS remains unclear.
Hypotheses explaining the pathophysiological mechanism of CFS include morphological and metabolic alterations in the brain, diminished central activation of muscles, altered central nervous system functioning, a neuroendocrine disturbance, or cognitive impairment. Furthermore, the presence of an underlying immunological problem has been suggested as an explanation for CFS.
If an underlying immunological problem is present, PCF and CFS patients might have an altered response to vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •- 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
结局指标
主要结局
Humoral and cellular immune responses after influenza vaccination in patients with postcancer fatigue and in patients with chronic fatigue syndrome.
时间窗: 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.
次要结局
未报告次要终点