An Explorative Study on Physiological and Neurophysiological Determinants of Fatigue in Cancer Survivors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Radboud University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01096641
First received: March 30, 2010
Last updated: June 21, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Postcancer Fatigue
Behavioral: immediate CBT
Behavioral: Delayed CBT

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 57
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)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Treated for a malignant solid tumour.
  • Completion of treatment for cancer minimal 1 year ago
  • Single treatment modality surgery permitted
  • Current hormonal therapy permitted
  • Disease-free, as defined by the absence of somatic disease activity parameters.
  • Age between 19 and 65.
  • Age at disease onset minimal 18 years

Exclusion Criteria:

  • Brain tumour in the past
  • Current psychological or psychiatric treatment.
  • Physical comorbidity which could explain the fatigue.
  • Contra-indication for MR examinations (e.g. claustrophobia).
  • Treatment with anti-depressive drugs, anti-epileptic drugs, benzodiazepines.
  • Insufficient command of the Dutch language to fill out questionnaires.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096641

Locations
Netherlands
University Medical Centre Nijmegen
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: H.W.M. van Laarhoven, Md University Medical Centre Nijmegen
  More Information

No publications provided by Radboud University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01096641     History of Changes
Other Study ID Numbers: FICS 20084002
Study First Received: March 30, 2010
Last Updated: June 21, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
Fatigued disease-free Cancer Patients
cancer treatment finished > one year and < ten years ago

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014