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

March 21, 2016 updated by: German Cancer Research Center

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • National Center for Tumor Diseases Heidelberg (German Cancer Research Center/University Hospital Heidelberg)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control group
No intervention
EXPERIMENTAL: Strength training group
12 weeks of progressive strength training
Behavioral: Progressive strength training
12 weeks of supervised progressive strength training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cancer related fatigue
Time Frame: From baseline to the 6th and 12th week of training.
Assessed via the Multidimensional Fatigue Inventory (MFI).
From baseline to the 6th and 12th week of training.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline to the 12th week of training.
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.
From baseline to the 12th week of training.
Change in body composition
Time Frame: From baseline to the 12th week of training
Assessed via bio-impedance measurement.
From baseline to the 12th week of training
Change in quality of life
Time Frame: From baseline to the 6th and 12th week of training.
Assessed via the EORTC QLQ C30.
From baseline to the 6th and 12th week of training.
Change in depression
Time Frame: From baseline to the 6th and 12th week of training.
Assessed via "Allgemeine Depressionsskala" (ADS).
From baseline to the 6th and 12th week of training.
Time of the first tumor progression under TKI therapy
Time Frame: Within the first 6 months of TKI therapy
Within the first 6 months of TKI therapy
Time of reduction or replacement of TKI therapy
Time Frame: Within the first 6 months of TKI therapy
Within the first 6 months of TKI therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Cancer Research Center

Investigators

  • Principal Investigator: Carsten Grüllich, MD, National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) Germany
  • Principal Investigator: Friederike Scharhag-Rosenberger, PhD, National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) Germany
  • Principal Investigator: Joachim Wiskamann, PhD, National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) Germany
  • Study Chair: Dirk Jäger, Professor, National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) Germany
  • Study Chair: Karen Steindorf, Professor, National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

June 11, 2012

First Submitted That Met QC Criteria

July 19, 2012

First Posted (ESTIMATE)

July 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 22, 2016

Last Update Submitted That Met QC Criteria

March 21, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-154/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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