NCT01645150CompletedNot Applicable
Pilot Study on the Effects of Strength Training on Cancer Related Fatigue in Cancer Patients During Tyrosine Kinase Inhibitor Therapy
German Cancer Research Center1 site in 1 country20 target enrollmentStarted: May 1, 2012Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in cancer related fatigue
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Strength training group
Experimental
12 weeks of progressive strength training
Intervention: Progressive strength training (Behavioral)
Control group
No Intervention
No intervention
Outcomes
Primary Outcomes
Change in cancer related fatigue
Time Frame: From baseline to the 6th and 12th week of training.
Assessed via the Multidimensional Fatigue Inventory (MFI).
Secondary Outcomes
- Change in muscle strength of the knee extensor, hip flexor and forearm flexor muscles.(From baseline to the 12th week of training.)
- Change in body composition(From baseline to the 12th week of training)
- Change in quality of life(From baseline to the 6th and 12th week of training.)
- Change in endurance capacity(From baseline to the 12th week of training.)
- Change in depression(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)
Investigators
Study Sites (1)
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