Reduction of Cancer Related Fatigue in Patients During TKI Therapy

Not Applicable

Completed

• Conditions: All Tumor Entities Treated With TKI Therapy
• Interventions: Behavioral: Progressive strength training

• Registration Number: NCT01645150
• Lead Sponsor: German Cancer Research Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-11
• Study First Submitted QC: 2012-07-19
• Study First Posted: 2012-07-20
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-21
• Last Update Posted: 2016-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Strength training group	Progressive strength training	12 weeks of progressive strength training

Primary Outcome Measures

Name	Time	Method
Change in cancer related fatigue	From baseline to the 6th and 12th week of training.	Assessed via the Multidimensional Fatigue Inventory (MFI).

Secondary Outcome Measures

Name	Time	Method
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.
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 depression	From baseline to the 6th and 12th week of training.	Assessed via "Allgemeine Depressionsskala" (ADS).
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

Trial Locations

Locations (1)

National Center for Tumor Diseases Heidelberg (German Cancer Research Center/University Hospital Heidelberg); 🇩🇪 Heidelberg, Germany