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An explorative study on physiological and neurophysiological determinants of fatigue in cancer survivors.

An explorative study on physiological and neurophysiological determinants of fatigue in cancer survivors.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20578
Enrollment
78
Registered
2009-02-24
Start date
2008-09-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vermoeidheid na kanker

Interventions

In this explorative study, disease-free cancer patients who finished treatment for cancer at least one year ago, will be approached for this study. Patients who are suitable for this study, based on t

Sponsors

Radboud University Nijmegen Medical Center; Department of Medical Oncology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Treated for a malignant, solid tumor; 2. Completion of treatment for cancer minimal 1 year ago; 3. Disease-free, as defined by the absence of somatic disease activity parameters; 4. Age between 19 and 65; 5. Age at disease onset minimal 18.

Exclusion criteria

Exclusion criteria: 1. Current psychological or psychiatric treatment; 2. Physical comorbidity which could explain the fatigue; 3. Contra-indication for MR-examinations; 4. Treatment with anti-depressive drugs, anti-epileptic drugs, or benzodiazepines; 5. Insufficient command of the Dutch language to fill out questionnaires.

Design outcomes

Primary

MeasureTime frame
The baseline and second assessment both include: 1. Magnetic resonance imaging (MRI) and magnetic resonance spectroscopy to assess brain morphology and brain metabolites, respectively; 2. A two-minute endurance test will be administered at maximal voluntary (isometric) contraction to assess peripheral and central fatigue. During the test changes in EMG and force indicate peripheral fatigue, while central fatigue is studied by the twitch interpolation technique; 3. A maximal exercise test will be performed to assess physical fitness and deconditioning; 4. Fatigue severity will be measured using the Checklist Individual Strength. The Checklist Individual Strength is designed to measure fatigue severity, concentration, motivation, and physical activity; 5. Additional questionnaires will be used to measure general health, the impact of the disease on daily life, difficulties in getting over the cancer experience, depression, anxiety, sleep, social support, physical activity, quality of life, and self efficacy; 6. Patients will perform neurological tests to assess information processing and motor speed; 7. Blood and urine samples of the patients will be analyzed to find possible explanations for cancer related fatigue; 8. Daily observed fatigue will be measured during a two-week period with the Self-Observation List. The latter instrument gives the actual level of daily fatigue and will be used during two weeks; 9. Daily activity will be measured during two weeks using an actometer. The actometer used is a motion-sensing device that can register and quantify human physical activity. To assess the effect of the maximal exercise test on the daily activity of patients, they will wear the actometer for an additional five days after the maximal exercise test.

Contacts

Public ContactH. Prinsen

Department of Medical Oncology (452) Radboud University Nijmegen Medical Centre PO Box 9101

h.prinsen@onco.umcn.nl+31 (0)24 3618765

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)