NCT01645150

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 11, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 20, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 22, 2016

Status Verified

March 1, 2016

Enrollment Period

3.6 years

First QC Date

June 11, 2012

Last Update Submit

March 21, 2016

Conditions

All Tumor Entities Treated With TKI Therapy

Keywords

physical activityexercisetrainingfatiguecancerTKItyrosine kinase inhibitor

Outcome Measures

Primary Outcomes (1)

  • Change in cancer related fatigue

    Assessed via the Multidimensional Fatigue Inventory (MFI).

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

Secondary Outcomes (7)

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

    From baseline to the 12th week of training.

  • Change in endurance capacity

    From baseline to the 12th week of training.

  • Change in body composition

    From baseline to the 12th week of training

  • Change in quality of life

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

  • Change in depression

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

  • +2 more secondary outcomes

Study Arms (2)

Strength training group

EXPERIMENTAL

12 weeks of progressive strength training

Behavioral: Progressive strength training

Control group

NO INTERVENTION

No intervention

Interventions

Progressive strength trainingBEHAVIORAL

12 weeks of supervised progressive strength training

Strength training group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Heidelberg, 69120, Germany

Location

Related Publications (1)

  • 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.

    PMID: 28667563DERIVED

MeSH Terms

Conditions

Motor ActivityFatigueNeoplasms

Condition Hierarchy (Ancestors)

BehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2012

First Posted

July 20, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 22, 2016

Record last verified: 2016-03

Locations

DE(1)