Reduction of Cancer Related Fatigue in Patients During TKI Therapy

NCT ID: NCT01645150

Last Updated: 2016-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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All Tumor Entities Treated With TKI Therapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Strength training group

12 weeks of progressive strength training

Group Type EXPERIMENTAL

Progressive strength training

Intervention Type BEHAVIORAL

12 weeks of supervised progressive strength training

Control group

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Progressive strength training

12 weeks of supervised progressive strength training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Cancer Research Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carsten Grüllich, MD

Role: PRINCIPAL_INVESTIGATOR

National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) Germany

Friederike Scharhag-Rosenberger, PhD

Role: PRINCIPAL_INVESTIGATOR

National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) Germany

Joachim Wiskamann, PhD

Role: PRINCIPAL_INVESTIGATOR

National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) Germany

Dirk Jäger, Professor

Role: STUDY_CHAIR

National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) Germany

Karen Steindorf, Professor

Role: STUDY_CHAIR

National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) Germany

Locations

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

Heidelberg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 28667563 (View on PubMed)

Other Identifiers

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S-154/2012

Identifier Type: -

Identifier Source: org_study_id

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