All Tumor Entities Treated With TKI TherapyRECAPNCT01645150
Reduction of Cancer Related Fatigue in Patients During TKI Therapy
A study testing Progressive strength training in people with All Tumor Entities Treated With TKI Therapy, run by German Cancer Research Center at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- All Tumor Entities Treated With TKI Therapy
- What is being tested?
- Progressive strength training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- May 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Acute infectious diseases
- No ambulatory ability
- Severe neurological disorders
- Severe cardiovascular diseases
- Severe pulmonary insufficiency
- Severe renal insufficiency
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- Other current tumor diseases
- Conditions rendering compliance impossible
- Participation in regular strength training
Trial locations and contacts
1 site in 1 country.
Germany1 site
National Center for Tumor Diseases Heidelberg (German Cancer Research Center/University Hospital Heidelberg)
Heidelberg, 69120
About this study
Official title: 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.
- Being tested
- Progressive strength training
- Keywords
- physical activity, exercise, training, fatigue, cancer, TKI, tyrosine kinase inhibitor
- Medical subject headings
- Motor Activity, Fatigue, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive strength trainingBehavioural
12 weeks of supervised progressive strength training
| Study group | Role | What they receive |
|---|---|---|
| Strength training group | Experimental | 12 weeks of progressive strength training Receives: Behavioral: Progressive strength training |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cancer related fatigue
Assessed via the Multidimensional Fatigue Inventory (MFI).
Measured: 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.
Assessed isokinetically and isometrically via an IsoMed2000 test system.
Measured: From baseline to the 12th week of training.
Change in endurance capacity
Maximal oxygen uptake (VO2max) assessed in a maximal incremental cycling test.
Measured: From baseline to the 12th week of training.
Change in body composition
Assessed via bio-impedance measurement.
Measured: From baseline to the 12th week of training
Change in quality of life
Assessed via the EORTC QLQ C30.
Measured: From baseline to the 6th and 12th week of training.
Change in depression
Assessed via "Allgemeine Depressionsskala" (ADS).
Measured: From baseline to the 6th and 12th week of training.
Time of the first tumor progression under TKI therapy
Measured: Within the first 6 months of TKI therapy
Time of reduction or replacement of TKI therapy
Measured: Within the first 6 months of TKI therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for All Tumor Entities Treated With TKI TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Cancer Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carsten Grüllich, MD, Principal investigator, National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) GermanyFriederike Scharhag-Rosenberger, PhD, Principal investigator, National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) GermanyJoachim Wiskamann, PhD, Principal investigator, National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) GermanyDirk Jäger, Professor, Study chair, National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) GermanyKaren Steindorf, Professor, Study chair, National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645150
- Sponsor's protocol ID
- S-154/2012
- Acronym
- RECAP
- Status last verified
- Mar 2016
- First submitted
- 11 Jun 2012
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28667563
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Effects of Strength Training on Cancer Related Fatigue in Cancer Patients During Tyrosine Kinase Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT01645150
- Acronym / sponsor ID
- RECAP / S-154/2012
- Keywords
- physical activity, exercise, training, fatigue, cancer, TKI, tyrosine kinase inhibitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- German Cancer Research CenterUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strength training group | Experimental | Behavioral: Progressive strength training12 weeks of progressive strength training |
| Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- Acute infectious diseases
- No ambulatory ability
- Severe neurological disorders
- Severe cardiovascular diseases
- Severe pulmonary insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive strength training12 weeks of supervised progressive strength training | Behavioural | Strength training group |
Primary outcome
Change in cancer related fatigue
Time frame: From baseline to the 6th and 12th week of training.
Assessed via the Multidimensional Fatigue Inventory (MFI).
7 secondary outcomes
Change in muscle strength of the knee extensor, hip flexor and forearm flexor muscles.
Time frame: From baseline to the 12th week of training.
Change in endurance capacity
Time frame: From baseline to the 12th week of training.
Change in body composition
Time frame: 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.
Change in depression
Time frame: 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
Time of reduction or replacement of TKI therapy
Time frame: Within the first 6 months of TKI therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
- Derived from this study: PubMed 28667563Rosenberger 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carsten Grüllich, MD principal investigator
National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) Germany
Friederike Scharhag-Rosenberger, PhD principal investigator
National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) Germany
Joachim Wiskamann, PhD principal investigator
National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive strength training in people with All Tumor Entities Treated With TKI Therapy, run by German Cancer Research Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cancer related fatigue (time frame: From baseline to the 6th and 12th week of training.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01645150, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2016.