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

NCT01096641 | Unknown

• 1 other identifier: FICS 20084002
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postcancer Fatigue

Keywords

Fatigued disease-free Cancer Patients; cancer treatment finished > one year and < ten years ago

Outcome Measures

Primary Outcomes (1)

• Possible (neuro)physiological determinants of postcancer fatigue

  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.

  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)

Study Arms (3)

Fatigued patients: Immediate start CBT

OTHER

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

fatigues patients: delayed CBT (after 6 months)

OTHER

The fatigued patients on the waiting list will start with CBT after 6 months

Behavioral: Delayed CBT

non-fatiqued controls

NO INTERVENTION

Non-fatigued control group. This group is not included in the randomization.

Interventions

immediate CBT BEHAVIORAL

After the baseline assessment the fatigued patients will be randomized to start immediately with Cognitive Behaviour Therapy, especially designed for fatigued cancer patients

Fatigued patients: Immediate start CBT

Delayed CBT BEHAVIORAL

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.

fatigues patients: delayed CBT (after 6 months)

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

University Medical Centre Nijmegen

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (5)

• Muller F, Wijayanto F, Abrahams H, Gielissen M, Prinsen H, Braamse A, van Laarhoven HWM, Groot P, Heskes T, Knoop H. Potential mechanisms of the fatigue-reducing effect of cognitive-behavioral therapy in cancer survivors: Three randomized controlled trials. Psychooncology. 2021 Sep;30(9):1476-1484. doi: 10.1002/pon.5710. Epub 2021 May 3.

  PMID: 33899978 DERIVED

• Ter Veer E, Prinsen H, Sprangers MAG, Zwinderman KAH, Bleijenberg G, van der Pouw Kraan TCTM, de Vries IJM, Wierenga EA, van Laarhoven HWM. Interferon Gamma-Induced Protein (IP-10) as Potential Biomarker for Cancer-Related-Fatigue: Results from a 6-month Randomized Controlled Trial. Cancer Invest. 2018;36(7):371-377. doi: 10.1080/07357907.2018.1499933. Epub 2018 Sep 6.

  PMID: 30188739 DERIVED

• Prinsen H, Heerschap A, Bleijenberg G, Zwarts MJ, Leer JW, van Asten JJ, van der Graaf M, Rijpkema M, van Laarhoven HW. Magnetic resonance spectroscopic imaging and volumetric measurements of the brain in patients with postcancer fatigue: a randomized controlled trial. PLoS One. 2013 Sep 11;8(9):e74638. doi: 10.1371/journal.pone.0074638. eCollection 2013.

  PMID: 24040301 DERIVED

• Prinsen H, Bleijenberg G, Heijmen L, Zwarts MJ, Leer JW, Heerschap A, Hopman MT, van Laarhoven HW. The role of physical activity and physical fitness in postcancer fatigue: a randomized controlled trial. Support Care Cancer. 2013 Aug;21(8):2279-88. doi: 10.1007/s00520-013-1784-9. Epub 2013 Mar 22.

  PMID: 23519566 DERIVED

• Prinsen H, Bleijenberg G, Zwarts MJ, Hopman MT, Heerschap A, van Laarhoven HW. Physiological and neurophysiological determinants of postcancer fatigue: design of a randomized controlled trial. BMC Cancer. 2012 Jun 18;12:256. doi: 10.1186/1471-2407-12-256.

  PMID: 22708881 DERIVED

Study Officials

• H.W.M. van Laarhoven, Md

  University Medical Centre Nijmegen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2010
• First Posted: March 31, 2010
• Study Start: April 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: June 22, 2012

Record last verified: 2012-06

Locations

NL (1)