Pancreatic NeoplasmsSTOPCNCT01395563
Strength Training on Pancreatic Cancer
A study testing strength training in people with Pancreatic Neoplasms and Cachexia, run by German Cancer Research Center at 3 sites in Germany.
Trial summary
The purpose of this study is to determine whether prednisone, methotrexate, and cyclophosphamide are effective in the treatment of rapidly progressive hearing loss in both ears due to autoimmune inner ear disease (AIED). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Neoplasms, Cachexia, Myopathy
- What is being tested?
- strength training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesGermany
- Study dates
- Jan 2009to Dec 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with pancreatic carcinomas after surgery (resection or exploration)
- given consent
Who cannot join
- acute infection
- pain
- no mobility or ability for walking or standing
- severe neurological disorders (apoplex, morbus Parkinson, paresis of the lower extremeties)
- severe cardiac or cardiovascular diseases (z.B. heart insufficiency NYHA III, myocardial infarction <3 months)
- rhytmical disorders, that contraindicate ergospirometric examinations
Show all 11Show fewer
- cardiac therapy with digitalis pharmacy
- unclear syncopes
- severe pulmonal insufficiency
- renal insufficiency (GFR < 30% at Krea >3 mg/dl)
- synchronous participation in an other clinical trial
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
European Pancreas Center
Heidelberg, 69120
German Cancer Research Center
Heidelberg, 69120
Technische Universität München
Munich, 81675
About this study
The purpose of this study is to determine whether prednisone, methotrexate, and cyclophosphamide are effective in the treatment of rapidly progressive hearing loss in both ears due to autoimmune inner ear disease (AIED).
Read the detailed description
Sudden out-of-hospital cardiac arrest (OOH-CA) remains a significant cause of death, in spite of recent declines in overall mortality from cardiovascular disease. Existing methods of emergency resuscitation are inadequate due to time delays inherent in the transport of a trained responder with defibrillation capabilities to the side of the OOH-CA victim. Existing Emergency Medical Services (EMS) systems typically combine paramedic Emergency Medical Technician (EMT) services with some level of community involvement, such as bystander cardiopulmonary resuscitation (CPR) training. Some communities include automated external defibrillators (AEDs) at isolated sites or in mobile police or fire vehicles. A comprehensive, integrated community approach to treatment with AEDs would have community units served by these volunteer non-medical responders who can quickly identify and treat a patient with OOH-CA. Such an approach is termed Public Access Defibrillation (PAD).
- Conditions
- Pancreatic Neoplasms, Cachexia, Myopathy
- Being tested
- strength training
- Medical subject headings
- Pancreatic Neoplasms, Cachexia, Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
strength trainingBehavioural
Also called progressive resistance training, sports, muscle hypertrophia, cachexia
strength training, high intensity, twice up to 3 times per week
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | pancreatic cancer patients Receives: Behavioral: strength training |
| 2 | Experimental | pancreatic cancer patients Receives: Behavioral: strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle mass and strength
Measured: after 8 weeks of intervention
Secondary outcomes (1)
quality of life
Measured: after 8 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2011 (estimated)
- Study startJan 2009
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Cancer Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University, Technical University of Munich
- Investigators
- Jens Werner, Prof. Dr. med., Principal investigator, Heidelberg UniversityHolger Krakowski-Roosen, Dr., Principal investigator, German CRCMarc Martignoni, PD Dr. med., Principal investigator, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395563
- Sponsor's protocol ID
- GermanCRC
- Acronym
- STOPC
- Status last verified
- Mar 2015
- First submitted
- 4 Dec 2009
- Last updated
- 13 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength Training on Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01395563
- Acronym / sponsor ID
- STOPC / GermanCRC
- Conditions
- Pancreatic Neoplasms, Cachexia, Myopathy
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- German Cancer Research CenterUniversity, hospital or other
- Collaborators
- Heidelberg University, Technical University of Munich
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 15 Jul 2011 (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 study is to determine whether prednisone, methotrexate, and cyclophosphamide are effective in the treatment of rapidly progressive hearing loss in both ears due to autoimmune inner ear disease (AIED).
Detailed description
Sudden out-of-hospital cardiac arrest (OOH-CA) remains a significant cause of death, in spite of recent declines in overall mortality from cardiovascular disease. Existing methods of emergency resuscitation are inadequate due to time delays inherent in the transport of a trained responder with defibrillation capabilities to the side of the OOH-CA victim. Existing Emergency Medical Services (EMS) systems typically combine paramedic Emergency Medical Technician (EMT) services with some level of community involvement, such as bystander cardiopulmonary resuscitation (CPR) training. Some communities include automated external defibrillators (AEDs) at isolated sites or in mobile police or fire vehicles. A comprehensive, integrated community approach to treatment with AEDs would have community units served by these volunteer non-medical responders who can quickly identify and treat a patient with OOH-CA. Such an approach is termed Public Access Defibrillation (PAD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: strength trainingpancreatic cancer patients |
| 2 | Experimental | Behavioral: strength trainingpancreatic cancer patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients with pancreatic carcinomas after surgery (resection or exploration)
- given consent
Key exclusion criteria (11 listed)
- acute infection
- pain
- no mobility or ability for walking or standing
- severe neurological disorders (apoplex, morbus Parkinson, paresis of the lower extremeties)
- severe cardiac or cardiovascular diseases (z.B. heart insufficiency NYHA III, myocardial infarction <3 months)
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 |
|---|---|---|
| strength trainingAlso: progressive resistance training, sports, muscle hypertrophia, cachexiastrength training, high intensity, twice up to 3 times per week | Behavioural | 1, 2 |
Primary outcome
muscle mass and strength
Time frame: after 8 weeks of intervention
1 secondary outcome
quality of life
Time frame: after 8 weeks of intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2015.
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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.
Jens Werner, Prof. Dr. med. principal investigator
Heidelberg University
Holger Krakowski-Roosen, Dr. principal investigator
German CRC
Marc Martignoni, PD Dr. med. principal investigator
Technical University of Munich
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing strength training in people with Pancreatic Neoplasms and Cachexia, run by German Cancer Research Center at 3 sites 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 2 inclusion and 11 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: withdrawn, as of the sponsor's last update on 13 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
muscle mass and strength (time frame: after 8 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2015.