Clinical trial NCT01645150: Reduction of Cancer Related Fatigue in Patients During TKI Therapy
Official title: Pilot Study on the Effects of Strength Training on Cancer Related Fatigue in Cancer Patients During Tyrosine Kinase Inhibitor Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: All Tumor Entities Treated With TKI Therapy
Keywords: physical activity
exercise
training
fatigue
cancer
TKI
tyrosine kinase inhibitor
Lead sponsor: German Cancer Research Center
Sponsor class: OTHER
First posted: 2012-07-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to determine the effects of a 12-week resistance training program on cancer related fatigue in cancer patients receiving tyrosine kinase inhibitor (TKI) therapy. It is hypothesized that incidence and severity of cancer related fatigue can be reduced by exercise training in this population which leads to an improved treatment completion rate.


Eligibility criteria: Inclusion Criteria:

* Male and female cancer patients
* Prior to tyrosine kinase inhibitor therapy (any substance, any line)
* Age: at least 18 yrs
* Body mass index (BMI): at least 18 kg/m2
* ECOG performance status: at most 2
* Must be able to meet the requirements of the study protocol

Exclusion Criteria:

* Acute infectious diseases
* No ambulatory ability
* Severe neurological disorders
* Severe cardiovascular diseases
* Severe pulmonary insufficiency
* Severe renal insufficiency
* Other current tumor diseases
* Conditions rendering compliance impossible
* Participation in regular strength training

Primary outcomes:
measure: Change in cancer related fatigue
timeFrame: From baseline to the 6th and 12th week of training.
Secondary outcomes:
measure: Change in muscle strength of the knee extensor, hip flexor and forearm flexor muscles.
timeFrame: From baseline to the 12th week of training.
measure: Change in endurance capacity
timeFrame: From baseline to the 12th week of training.
measure: Change in body composition
timeFrame: From baseline to the 12th week of training
measure: Change in quality of life
timeFrame: From baseline to the 6th and 12th week of training.
measure: Change in depression
timeFrame: From baseline to the 6th and 12th week of training.
measure: Time of the first tumor progression under TKI therapy
timeFrame: Within the first 6 months of TKI therapy
measure: Time of reduction or replacement of TKI therapy
timeFrame: Within the first 6 months of TKI therapy
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: National Center for Tumor Diseases Heidelberg (German Cancer Research Center/University Hospital Heidelberg)
Study officials:
affiliation: National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) Germany
name: Carsten Grüllich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) Germany
name: Friederike Scharhag-Rosenberger, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) Germany
name: Joachim Wiskamann, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) Germany
name: Dirk Jäger, Professor
role: STUDY_CHAIR
affiliation: National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) Germany
name: Karen Steindorf, Professor
role: STUDY_CHAIR
References:
citation: Rosenberger F, Wiskemann J, Vallet S, Haag GM, Schembri E, Jager D, Grullich C. Resistance training as supportive measure in advanced cancer patients undergoing TKI therapy-a controlled feasibility trial. Support Care Cancer. 2017 Dec;25(12):3655-3664. doi: 10.1007/s00520-017-3788-3. Epub 2017 Jun 30.