An Explorative Study on Physiological and Neurophysiological Determinants of Fatigue in Cancer Survivors
Recruitment status was: Active, not recruiting
Postcancer fatigue is a severe and invalidating problem, impairing quality of life. About 20 to 40% of the patients remain fatigued, at least one year after successful cancer treatment. Fortunately, there is an effective treatment for postcancer fatigue; cognitive behavior therapy. However, no cause for postcancer fatigue has been identified yet. The aim of the study is to identify factors that (partly) cause postcancer fatigue to improve the theoretical understanding of fatigue and to improve the diagnostics of fatigue, predict therapy outcome, and facilitate other treatment options.
In this study, disease-free fatigued cancer patients, who finished treatment for cancer at least one year and maximally ten years ago, will be approached for this study. They will be compared to non-fatigued patients.
First, a baseline assessment will take place. Magnetic resonance imaging of the brains will be performed to assess brain volume and magnetic resonance spectroscopy will be performed to measure the concentrations of specific substances in the brains. Changes in the volume of parts of the brains have been observed in (non-cancer) patients with the chronic fatigue syndrome (CFS), in comparison with healthy controls. In addition, abnormal concentrations of specific substances have been observed in patients with CFS compared to healthy controls. To assess muscle fatigue, a two-minute endurance test of the upper arm will be administered at maximal voluntary contraction. Next to differences in the brains, CFS patients showed (central) muscle fatigue. A maximal exercise test on a bicycle will be performed to assess physical fitness. Physical activity in fatigued cancer survivors is decreased, compared to healthy controls. It is not known whether physical deconditioning originated during the cancer treatment is the reason why these patients are still less active. In addition, patients and controls will wear an actometer for two weeks to register baseline daily physical activity and for an additional 5 days after the maximal exercise test, to assess the effect of exercise on the daily physical activity. Finally, patients and controls will complete standardized questionnaires and will perform neurological/psychological tests, like a reaction time test and a short time memory task, at baseline.
The results of the non-fatigued and the fatigued patients will be compared at baseline. For the non-fatigued participants, the study will be finished after the baseline measurements. The fatigued participants will start with cognitive behavior therapy immediately after the baseline measurements or after 6 months, depending on the randomization.
At the end of the therapy, after six months, or after 6 months of waiting for cognitive behavior therapy, a second assessment will take place, comparable to the baseline measurements. These results will be compared with the baseline situation to analyze the effect of cognitive behavior therapy on the (possible) causes of postcancer fatigue.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Explorative Study on Physiological and Neurophysiological Determinants of Fatigue in Cancer Survivors|
- Possible (neuro)physiological determinants of postcancer fatigue [ Time Frame: The measurements will be performed at baseline and comparable measurements will be performed 6 months later (after 6 months cognitive behavior therapy or 6 months waiting list condition) ] [ Designated as safety issue: No ]MRI to assess brain morphology; MRS to assess brain metabolite concentrations; sEMG and force registration to assess central and peripheral muscle fatigue; maximal exercise test to assess physical condition; actometer measurements and self-observation list to assess daily activity and symptoms; standardized questionnaires to assess fatigue severity and general health; neurological tests to assess information processing and motor speed; screening of blood and urine to find possible explanations for postcancer fatigue.
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||October 2012|
|Estimated Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Fatigued patients: Immediate start CBT
After the baseline assessment the fatigued patients will be randomized to start immediately with Cognitive Behaviour Therapy, especially designed for fatigued cancer patients. At the end of the therapy, after 6 months, a second assessment will take place.This assessment will include the same measurements as at baseline.
Behavioral: immediate CBT
After the baseline assessment the fatigued patients will be randomized to start immediately with Cognitive Behaviour Therapy, especially designed for fatigued cancer patients
fatigues patients: delayed CBT (after 6 months)
The fatigued patients on the waiting list will start with CBT after 6 months
Behavioral: Delayed CBT
After the baseline assessment the fatigued patients will be randomized: this group is to be placed on a waiting list. After 6 months, a second assessment will take place in the group of fatigued patients who received CBT immediately after randomization. This assessment will include the same measurements as at baseline. The fatigued patients on the waiting list will then start with CBT.
No Intervention: non-fatiqued controls
Non-fatigued control group. This group is not included in the randomization.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01096641
|University Medical Centre Nijmegen|
|Nijmegen, Netherlands, 6500 HB|
|Principal Investigator:||H.W.M. van Laarhoven, Md||University Medical Centre Nijmegen|