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 enrollmentMay 2012

ConditionsAll Tumor Entities Treated With TKI Therapy

Overview

Phase: N/A
Intervention: Not specified
Conditions: All Tumor Entities Treated With TKI Therapy
Sponsor: German Cancer Research Center
Enrollment: 20
Locations: 1
Primary Endpoint: Change in cancer related fatigue
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

May 2012

End Date

December 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

German Cancer Research Center

Responsible Party

Sponsor

Eligibility Criteria

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

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 body composition(From baseline to the 12th week of training)
Change in muscle strength of the knee extensor, hip flexor and forearm flexor muscles.(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)