Trial Information
Pilot Study on the Effects of Strength Training on Cancer Related Fatigue in Patients With Renal Cell Carcinoma Under Tyrosin Kinase Inhibitor Therapy
Inclusion Criteria:
- Male and female patients with histologically confirmed renal cell carcinoma
- Prior to tyrosine kinase inhibitor therapy
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Change in cancer related fatigue
Outcome Description:
Assessed via the Multidimensional Fatigue Inventory (MFI).
Outcome Time Frame:
From baseline to the 6th and 12th week of training.
Safety Issue:
No
Principal Investigator
Carsten GrĂ¼llich, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) Germany
Authority:
Germany: Ethics Committee of the Medical Faculty Heidelberg
Study ID:
S-154/2012
NCT ID:
NCT01645150
Start Date:
May 2012
Completion Date:
December 2014
Related Keywords:
- Renal Cell Carcinoma
- physical activity
- exercise
- training
- fatigue
- cancer
- renal cell carcinoma
- tyrosine kinase inhibitor
- Carcinoma
- Carcinoma, Renal Cell
- Fatigue