All Tumor Entities Treated With TKI Therapy
Conditions
Keywords
physical activity, exercise, training, fatigue, cancer, TKI, tyrosine kinase inhibitor
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.
Interventions
BEHAVIORALProgressive strength training
12 weeks of supervised progressive strength training
Sponsors
German Cancer Research Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cancer related fatigue | From baseline to the 6th and 12th week of training. | Assessed via the Multidimensional Fatigue Inventory (MFI). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in endurance capacity | From baseline to the 12th week of training. | Maximal oxygen uptake (VO2max) assessed in a maximal incremental cycling test. |
| Change in body composition | From baseline to the 12th week of training | Assessed via bio-impedance measurement. |
| Change in quality of life | From baseline to the 6th and 12th week of training. | Assessed via the EORTC QLQ C30. |
| Change in muscle strength of the knee extensor, hip flexor and forearm flexor muscles. | From baseline to the 12th week of training. | Assessed isokinetically and isometrically via an IsoMed2000 test system. |
| 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 | — |
| Change in depression | From baseline to the 6th and 12th week of training. | Assessed via Allgemeine Depressionsskala (ADS). |
Countries
Germany
Outcome results
None listed