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Completed

NCT Number: NCT01645150

Reduction of Cancer Related Fatigue in Patients During TKI Therapy

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.

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Key information

Conditions

All Tumor Entities Treated With TKI Therapy Behavior Fatigue Motor Activity Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Center for Tumor Diseases Heidelberg (German Cancer Research Center/University Hospital Heidelberg)

Heidelberg, 69120, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Progressive strength training

Behavioral

12 weeks of supervised progressive strength training

Primary outcomes

  1. 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

  1. Change in muscle strength of the knee extensor, hip flexor and forearm flexor muscles.

    Time frame: From baseline to the 12th week of training.

    Assessed isokinetically and isometrically via an IsoMed2000 test system.

  2. Change in endurance capacity

    Time frame: From baseline to the 12th week of training.

    Maximal oxygen uptake (VO2max) assessed in a maximal incremental cycling test.

  3. Change in body composition

    Time frame: From baseline to the 12th week of training

    Assessed via bio-impedance measurement.

  4. Change in quality of life

    Time frame: From baseline to the 6th and 12th week of training.

    Assessed via the EORTC QLQ C30.

  5. Change in depression

    Time frame: From baseline to the 6th and 12th week of training.

    Assessed via "Allgemeine Depressionsskala" (ADS).

  6. Time of the first tumor progression under TKI therapy

    Time frame: Within the first 6 months of TKI therapy

  7. Time of reduction or replacement of TKI therapy

    Time frame: Within the first 6 months of TKI therapy

Sponsors and collaborators

Lead sponsor

German Cancer Research Center

Other

Registry information

Official study title

Pilot Study on the Effects of Strength Training on Cancer Related Fatigue in Cancer Patients During Tyrosine Kinase Inhibitor Therapy

Acronym: RECAP

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 20, 2012
Registry last updated
Mar 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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