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

Primary Purpose

All Tumor Entities Treated With TKI Therapy

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Progressive strength training
Sponsored by
German Cancer Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for All Tumor Entities Treated With TKI Therapy focused on measuring physical activity, exercise, training, fatigue, cancer, TKI, tyrosine kinase inhibitor

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Strength training group

Control group

Arm Description

12 weeks of progressive strength training

No intervention

Outcomes

Primary Outcome Measures

Change in cancer related fatigue
Assessed via the Multidimensional Fatigue Inventory (MFI).

Secondary Outcome Measures

Change in muscle strength of the knee extensor, hip flexor and forearm flexor muscles.
Assessed isokinetically and isometrically via an IsoMed2000 test system.
Change in endurance capacity
Maximal oxygen uptake (VO2max) assessed in a maximal incremental cycling test.
Change in body composition
Assessed via bio-impedance measurement.
Change in quality of life
Assessed via the EORTC QLQ C30.
Change in depression
Assessed via "Allgemeine Depressionsskala" (ADS).
Time of the first tumor progression under TKI therapy
Time of reduction or replacement of TKI therapy

Full Information

First Posted
June 11, 2012
Last Updated
March 21, 2016
Sponsor
German Cancer Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT01645150
Brief Title
Reduction of Cancer Related Fatigue in Patients During TKI Therapy
Acronym
RECAP
Official Title
Pilot Study on the Effects of Strength Training on Cancer Related Fatigue in Cancer Patients During Tyrosine Kinase Inhibitor Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
German Cancer Research Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
All Tumor Entities Treated With TKI Therapy
Keywords
physical activity, exercise, training, fatigue, cancer, TKI, tyrosine kinase inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Strength training group
Arm Type
Experimental
Arm Description
12 weeks of progressive strength training
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
Progressive strength training
Intervention Description
12 weeks of supervised progressive strength training
Primary Outcome Measure Information:
Title
Change in cancer related fatigue
Description
Assessed via the Multidimensional Fatigue Inventory (MFI).
Time Frame
From baseline to the 6th and 12th week of training.
Secondary Outcome Measure Information:
Title
Change in muscle strength of the knee extensor, hip flexor and forearm flexor muscles.
Description
Assessed isokinetically and isometrically via an IsoMed2000 test system.
Time Frame
From baseline to the 12th week of training.
Title
Change in endurance capacity
Description
Maximal oxygen uptake (VO2max) assessed in a maximal incremental cycling test.
Time Frame
From baseline to the 12th week of training.
Title
Change in body composition
Description
Assessed via bio-impedance measurement.
Time Frame
From baseline to the 12th week of training
Title
Change in quality of life
Description
Assessed via the EORTC QLQ C30.
Time Frame
From baseline to the 6th and 12th week of training.
Title
Change in depression
Description
Assessed via "Allgemeine Depressionsskala" (ADS).
Time Frame
From baseline to the 6th and 12th week of training.
Title
Time of the first tumor progression under TKI therapy
Time Frame
Within the first 6 months of TKI therapy
Title
Time of reduction or replacement of TKI therapy
Time Frame
Within the first 6 months of TKI therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carsten Grüllich, MD
Organizational Affiliation
National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Friederike Scharhag-Rosenberger, PhD
Organizational Affiliation
National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joachim Wiskamann, PhD
Organizational Affiliation
National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dirk Jäger, Professor
Organizational Affiliation
National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) Germany
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Karen Steindorf, Professor
Organizational Affiliation
National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) Germany
Official's Role
Study Chair
Facility Information:
Facility Name
National Center for Tumor Diseases Heidelberg (German Cancer Research Center/University Hospital Heidelberg)
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
28667563
Citation
Rosenberger F, Wiskemann J, Vallet S, Haag GM, Schembri E, Jager D, Grullich C. Resistance training as supportive measure in advanced cancer patients undergoing TKI therapy-a controlled feasibility trial. Support Care Cancer. 2017 Dec;25(12):3655-3664. doi: 10.1007/s00520-017-3788-3. Epub 2017 Jun 30.
Results Reference
derived

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Reduction of Cancer Related Fatigue in Patients During TKI Therapy

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