Postcancer FatigueNCT01651754
Humoral and Cellular Immune Responses After Influenza Vaccination in Patients With Postcancer Fatigue and in Patients With Chronic Fatigue Syndrome
A study testing Seasonal influenza vaccination in people with Postcancer Fatigue and Chronic Fatigue Syndrome, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postcancer Fatigue, Chronic Fatigue Syndrome
- What is being tested?
- Seasonal influenza vaccination
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2010to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Humoral and Cellular Immune Responses After Influenza Vaccination in Patients With Postcancer Fatigue and in Patients With Chronic Fatigue Syndrome.
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.
Read the detailed description
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.
Aim Therefore, the aim of this study is to compare the humoral and cellular immune responses upon vaccination, using seasonal influenza vaccination as a model of a vaccination, in PCF and CFS patients, non-fatigued cancer survivors, and healthy controls.
Research questions
- Is the humoral and/or cellular immune response after influenza vaccination different between fatigued patients (PCF and CFS) and non-fatigued individuals?
- Is the humoral and/or cellular immune response after influenza vaccination different between PCF and CFS patients? Design The immune responses upon influenza vaccination will be assessed in 20 PCF patients and in 20 CFS patients. As a control group for PCF patients, 20 non-fatigued cancer survivors will be included. Additionally, 20 healthy controls will participate in this study as a control group without a cancer history and without fatigue symptoms. These four groups will be age- and sex-matched.
At baseline, participants will complete the Checklist Individual Strength, a questionnaire about the current use of medicines, and a questionnaire about their vaccination history. All participants will be intramuscularly vaccinated with a single dose of the seasonal influenza vaccine. Peripheral blood mononuclear cells will be collected at baseline (day 1) and 7 days after vaccination (day 8), and serum will be collected at baseline and 21 days after vaccination (day 22). Half a year after vaccination, all participants will be contacted to check whether a possible infection by influenza had taken place in the meantime or not.
The humoral immune responses on influenza vaccination will measured at day 1 and day 22 in serum by the haemagglutination-inhibition antibody test. The cellular immune responses will be measured at day 1 and day 8 by T lymphocyte proliferation, activation, and cytokine secretion.
Relevance of this study To the best of our knowledge, we are the first to explore both the humoral and cellular immune responses after influenza vaccination in both PCF and CFS patients. By means of this study, we would like to improve the understanding of the underlying physiology of PCF and CFS.
- Conditions
- Postcancer Fatigue, Chronic Fatigue Syndrome
- Being tested
- Seasonal influenza vaccination
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seasonal influenza vaccinationBiological
single dose of influenza vaccination
| Study group | Role | What they receive |
|---|---|---|
| Seasonal influenza vaccination | Other | Not described Receives: Biological: Seasonal influenza vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: before vaccination, 1 and 3 weeks after vaccination (change in immune response from pre- to post-vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startSep 2010
- Primary completionAug 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postcancer FatigueStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- H.W.M. van Laarhoven, Md, Principal investigator, University Medical Centre Nijmegen st Radboud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651754
- Sponsor's protocol ID
- UMCNONCO201009
- Status last verified
- Jun 2012
- First submitted
- 21 Jun 2012
- Last updated
- 27 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Humoral and Cellular Immune Responses After Influenza Vaccination in Patients With Postcancer Fatigue and in Patients With Chronic Fatigue Syndrome.
- ClinicalTrials.gov ID
- NCT01651754
- Acronym / sponsor ID
- UMCNONCO201009
- Conditions
- Postcancer Fatigue, Chronic Fatigue Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 27 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Aim Therefore, the aim of this study is to compare the humoral and cellular immune responses upon vaccination, using seasonal influenza vaccination as a model of a vaccination, in PCF and CFS patients, non-fatigued cancer survivors, and healthy controls.
Research questions
- Is the humoral and/or cellular immune response after influenza vaccination different between fatigued patients (PCF and CFS) and non-fatigued individuals?
- Is the humoral and/or cellular immune response after influenza vaccination different between PCF and CFS patients? Design The immune responses upon influenza vaccination will be assessed in 20 PCF patients and in 20 CFS patients. As a control group for PCF patients, 20 non-fatigued cancer survivors will be included. Additionally, 20 healthy controls will participate in this study as a control group without a cancer history and without fatigue symptoms. These four groups will be age- and sex-matched.
At baseline, participants will complete the Checklist Individual Strength, a questionnaire about the current use of medicines, and a questionnaire about their vaccination history. All participants will be intramuscularly vaccinated with a single dose of the seasonal influenza vaccine. Peripheral blood mononuclear cells will be collected at baseline (day 1) and 7 days after vaccination (day 8), and serum will be collected at baseline and 21 days after vaccination (day 22). Half a year after vaccination, all participants will be contacted to check whether a possible infection by influenza had taken place in the meantime or not.
The humoral immune responses on influenza vaccination will measured at day 1 and day 22 in serum by the haemagglutination-inhibition antibody test. The cellular immune responses will be measured at day 1 and day 8 by T lymphocyte proliferation, activation, and cytokine secretion.
Relevance of this study To the best of our knowledge, we are the first to explore both the humoral and cellular immune responses after influenza vaccination in both PCF and CFS patients. By means of this study, we would like to improve the understanding of the underlying physiology of PCF and CFS.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Seasonal influenza vaccination | Other | Biological: Seasonal influenza vaccination |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seasonal influenza vaccinationsingle dose of influenza vaccination | Biological | Seasonal influenza vaccination |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
H.W.M. van Laarhoven, Md principal investigator
University Medical Centre Nijmegen st Radboud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seasonal influenza vaccination in people with Postcancer Fatigue and Chronic Fatigue Syndrome, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2012.