Reduction of Cancer Related Fatigue in Patients During TKI Therapy

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study on the Effects of Strength Training on Cancer Related Fatigue in Cancer Patients During Tyrosine Kinase Inhibitor Therapy

Conditions
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All Tumor Entities Treated With TKI Therapy

Intervention / Treatment
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* Behavioral: Progressive strength training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Strength training group<br>12 weeks of progressive strength training | Behavioral: Progressive strength training<br>* 12 weeks of supervised progressive strength training<br>|
| No Intervention: Control group<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cancer related fatigue | Assessed via the Multidimensional Fatigue Inventory (MFI). | From baseline to the 6th and 12th week of training. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle strength of the knee extensor, hip flexor and forearm flexor muscles. | Assessed isokinetically and isometrically via an IsoMed2000 test system. | From baseline to the 12th week of training. | 
| Change in endurance capacity | Maximal oxygen uptake (VO2max) assessed in a maximal incremental cycling test. | From baseline to the 12th week of training. | 
| Change in body composition | Assessed via bio-impedance measurement. | From baseline to the 12th week of training | 
| Change in quality of life | Assessed via the EORTC QLQ C30. | From baseline to the 6th and 12th week of training. | 
| Change in depression | Assessed via Allgemeine Depressionsskala (ADS). | From baseline to the 6th and 12th week of training. | 
| Time of the first tumor progression under TKI therapy |  | Within the first 6 months of TKI therapy | 
| Time of reduction or replacement of TKI therapy |  | Within the first 6 months of TKI therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, exercise, training, fatigue, cancer, TKI, tyrosine kinase inhibitor