Non Small Cell Lung CancerPhase 2POSITIVENCT01581346
Exercise Study in Patients With Lung Cancer
A Phase 2 study testing Exercise intervention in people with Non Small Cell Lung Cancer, run by German Cancer Research Center at 1 site in Germany.
Trial summary
In the course of their disease patients with Non small cell lung cancer (NSCLC) often experience impaired psychological and physical functioning resulting in a reduced quality of life (QoL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Exercise intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2011to Dec 2011
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients
- histological confirmed diagnosis of Non small cell lung cancer (NSCLC)
- current treatment: chemo-and/or radiotherapy
- age > 18y
- Body Mass Index (BMI) > 18
- written informed consent
Who cannot join
- acute infection
- immobility > 2 days
- severe neurological impairment
- severe cardiac impairment
- severe pulmonal impairment
- severe renal impairment
- acute bleedings
- alcohol-/drug-abuse
Trial locations and contacts
1 site in 1 country.
Germany1 site
Thoracic Oncology Clinic for Thoracic Diseases
Heidelberg, 69126
About this study
Official title: Pilot Study to Establish an Exercise Intervention in Patients With Lung Cancer
In the course of their disease patients with Non small cell lung cancer (NSCLC) often experience impaired psychological and physical functioning resulting in a reduced quality of life (QoL). The aim of the study is to explore the feasibility and the effects of an eight weeks combined muscle strength and endurance training on physical capacity and QoL.
Read the detailed description
In this open, prospective, single center study 40 patients (pts) with NSCLC undergoing adjuvant or palliative chemo-/ or radiotherapy are enrolled. Physical status is assessed by using the 6 Minute Walk Test (6MWT) for endurance and by using the Handheld Dynamometer (HHDM) for strength (flexion and extension of elbow, hip and knee). Psychological performance is measured by standardized questionnaires (MFI, FACT-L, PHQ - 9). Data are collected at baseline (T0) and after the 8 weeks sports intervention (T1). Pts are instructed to train at least 5 times/ week in the inpatient setting. After discharge pts are instructed to train in a home-based setting at least 3 times/week for a period of 8 weeks. Feasibility is defined as an adherence of two trainings per week during at least 6 weeks (out of 8 weeks of the intervention).
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Exercise intervention
- Keywords
- NSCLC, exercise intervention, quality of life
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pts were instructed to train at least 5 times/ week in the inpatient setting. After discharge pts were instructed to train in a home-based setting at least 3 times/week for a period of 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| exercise intervention | Experimental | Pts were instructed to train at least 5 times/ week in the inpatient setting. After discharge pts were instructed to train in a home-based setting at least 3 times/week for a period of 8 weeks. Receives: Other: Exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
- number of patients who are adherent to the exercise intervention
Adherence is defined as: completion of at least two training sessions per week during minimum six weeks out of eight weeks of the intervention.
Measured: 8 months
Secondary outcomes (2)
- effects of the exercise intervention on psychological symptoms (e.g. quality of life)
Quality of life will be measured by the standardized and validated questionnaire FACT-L;
Measured: 8 months
- effects of the exercise intervention on physical symptoms (muscle strength and endurance)
Muscle strength will be measured by hand held dynamometry and endurance by 6 Minute Walk Test
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startMar 2011
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies 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 2
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Cancer Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University
- Responsible party
- Sponsor
- Investigators
- Michael Thomas, MD, Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01581346
- Sponsor's protocol ID
- POSITIVE_II
- Acronym
- POSITIVE
- Status last verified
- Apr 2012
- First submitted
- 5 Apr 2012
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Establish an Exercise Intervention in Patients With Lung Cancer
- ClinicalTrials.gov ID
- NCT01581346
- Acronym / sponsor ID
- POSITIVE / POSITIVE_II
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- NSCLC, exercise intervention, quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- German Cancer Research CenterUniversity, hospital or other
- Collaborators
- Heidelberg University
- Study start
- Mar 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 20 Apr 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.
In the course of their disease patients with Non small cell lung cancer (NSCLC) often experience impaired psychological and physical functioning resulting in a reduced quality of life (QoL). The aim of the study is to explore the feasibility and the effects of an eight weeks combined muscle strength and endurance training on physical capacity and QoL.
Detailed description
In this open, prospective, single center study 40 patients (pts) with NSCLC undergoing adjuvant or palliative chemo-/ or radiotherapy are enrolled. Physical status is assessed by using the 6 Minute Walk Test (6MWT) for endurance and by using the Handheld Dynamometer (HHDM) for strength (flexion and extension of elbow, hip and knee). Psychological performance is measured by standardized questionnaires (MFI, FACT-L, PHQ - 9). Data are collected at baseline (T0) and after the 8 weeks sports intervention (T1). Pts are instructed to train at least 5 times/ week in the inpatient setting. After discharge pts are instructed to train in a home-based setting at least 3 times/week for a period of 8 weeks. Feasibility is defined as an adherence of two trainings per week during at least 6 weeks (out of 8 weeks of the intervention).
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| exercise intervention | Experimental | Other: Exercise interventionPts were instructed to train at least 5 times/ week in the inpatient setting. After discharge pts were instructed to train in a home-based setting at least 3 times/week for a period of 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female patients
- histological confirmed diagnosis of Non small cell lung cancer (NSCLC)
- current treatment: chemo-and/or radiotherapy
- age > 18y
- Body Mass Index (BMI) > 18
Key exclusion criteria (8 listed)
- acute infection
- immobility > 2 days
- severe neurological impairment
- severe cardiac impairment
- severe pulmonal impairment
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 |
|---|---|---|
| Exercise interventionPts were instructed to train at least 5 times/ week in the inpatient setting. After discharge pts were instructed to train in a home-based setting at least 3 times/week for a period of 8 weeks. | Other | exercise intervention |
Primary outcome
- number of patients who are adherent to the exercise intervention
Time frame: 8 months
Adherence is defined as: completion of at least two training sessions per week during minimum six weeks out of eight weeks of the intervention.
2 secondary outcomes
- effects of the exercise intervention on psychological symptoms (e.g. quality of life)
Time frame: 8 months
- effects of the exercise intervention on physical symptoms (muscle strength and endurance)
Time frame: 8 months
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 20 Apr 2012.
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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.
Michael Thomas, MD principal investigator
Heidelberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exercise intervention in people with Non Small Cell Lung Cancer, 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 8 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 20 Apr 2012. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
- number of patients who are adherent to the exercise intervention (time frame: 8 months). 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 20 Apr 2012.