Reduction of Cancer Related Fatigue in Patients During TKI Therapy (RECAP)

German Cancer Research Center

Status: Completed

Conditions: All Tumor Entities Treated With TKI Therapy

Treatments: Behavioral: Progressive strength training

Study type: Interventional

Funder types: Other

Identifiers

NCT01645150

S-154/2012

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Strength training group

Experimental group

Description:

12 weeks of progressive strength training

Treatment:

Behavioral: Progressive strength training

Control group

No Intervention group

Description:

No intervention