RECAP-Study
Reduction of Cancer Related Fatigue in Patients undergoing TKI Therapy
Abstract
For the treatment of metastasized carcinoma, antiangiogenic tyrosine kinase inhibitors (TKI) have been used in recent years. Up to 70 % of patients develop pronounced fatigue as a side effect of this treatment. This can result in dose-reduction or termination of the TKI therapy and is therefore relevant. For patient with non-metastasized diseases it is already documented that strength training has positive effects on fatigue. However, for patients in metastasized situations, there are currently no data available. In the RECAP Study, the feasibility and effects of strength training on fatigue in patients receiving TKI therapy is therefore investigated.
The RECAP Study is a descriptive, prospective, open, controlled clinical pilot intervention trial. Patients with advanced/metastasized and newly initiated TKI therapy are recruited for participation (all substances and all lines of treatment). Participants are allocated to either a strength training group or a treatment as usual group (control group without systematic strength training) depending on the distance between their residence and the study’s training facility. The intervention period lasts 12 weeks. Main outcome measure is the effect of the 12 week strength training program compared to treatment as usual on fatigue symptoms in patients receiving TKI therapy. Furthermore, quality of life, depression, physical fitness and body composition as well as therapy compliance are determined. These data are assessed by means of questionnaires, strength and endurance tests, and bioelectrical impedance analysis in the beginning of the study as well as after six and twelve weeks.
Recruitment started in July 2012 and is expected to be complete by December 2014. A total of 40 participants are to be recruited.
Contact
Prof. Dr. Friederike Rosenberger
Phone: +49 6221 56-35681
E-mail: friederike.rosenberger@nct-heidelberg.de