Extensive Stage Small Cell Lung CancerNCT01999881
Impacts of Exercise on Prognostic Biomarkers in Lung Cancer Patients
A study testing exercise intervention, standard follow-up care and quality-of-life assessment in people with Extensive Stage Small Cell Lung Cancer and Healthy, no Evidence of Disease, run by University of Wisconsin, Madison at 2 sites in United States.
Trial summary
This randomized pilot clinical trial studies exercise intervention in improving quality of life and exercise capacity and reducing inflammation and oxidative stress in patients with lung cancer and their support persons. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Extensive Stage Small Cell Lung Cancer, Healthy, no Evidence of Disease, Limited Stage Small Cell Lung Cancer
- What is being tested?
- exercise intervention, standard follow-up care and quality-of-life assessment
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2013to Feb 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- LUNG CANCER PATIENTS: A confirmed diagnosis of any stage lung cancer (non-small cell lung cancer [NSCLC] or small cell lung cancer [SCLC])
- LUNG CANCER PATIENTS: Can be receiving any type of treatment (chemotherapy, radiation therapy, both or neither) are eligible
- LUNG CANCER PATIENTS: Able to understand and read in English sufficiently to adequately complete informed consent to participate and to complete the questionnaires
- LUNG CANCER PATIENTS: For patients treated with curative intent, and who have not relapsed, they must be within 1 year of their diagnosis of lung cancer (determined by date of diagnostic pathology sample)
- SUPPORT PERSONS: Able to understand and read in English sufficiently to adequately complete informed consent to participate and to complete the questionnaires
Who cannot join
- LUNG CANCER PATIENTS: Symptomatic heart disease including congestive heart failure or arrhythmia
- LUNG CANCER PATIENTS: Documented myocardial infarction in the last three months
- LUNG CANCER PATIENTS: Central nervous system (CNS) metastases that results in impaired ability to participate in an exercise program at the discretion of the study physician
- LUNG CANCER PATIENTS: Any psychological or physical disease that would impair or prevent participation in an exercise program at the discretion of the study physician
- LUNG CANCER PATIENTS: Cognitive or reading impairments that would preclude them from completing questionnaires
- LUNG CANCER PATIENTS: Current participation in an exercise program
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- SUPPORT PERSONS: Symptomatic heart disease including congestive heart failure or arrhythmia
- SUPPORT PERSONS: Documented myocardial infarction in the last three months
- SUPPORT PERSONS: Cognitive or reading impairments that would preclude them from completing questionnaires
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UW Health Oncology - 1 South Park
Madison, Wisconsin, 53715
University of Wisconsin, Madison
Madison, Wisconsin, 53792
About this study
This randomized pilot clinical trial studies exercise intervention in improving quality of life and exercise capacity and reducing inflammation and oxidative stress in patients with lung cancer and their support persons. Exercise therapy may help improve quality of life, may increase exercise capacity, and may reduce inflammation and oxidative stress in patients with lung cancer and their supporters.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the effect of an eight-week exercise intervention on biomarkers of inflammation, oxidative stress, exercise capacity, and quality of life in lung cancer patients.
SECONDARY OBJECTIVES:
- Determine the effect of an eight-week exercise intervention on markers of stress and quality of life in the support person of lung cancer patients.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM A: Patients and their support persons undergo a supervised combined aerobic exercise comprising walking, cycling, or video-based aerobics and strength training using resistance bands for 40 minutes 2 days a week at the University of Wisconsin Hospital and Clinic (UWHC) and 3 days a week at home over 8 weeks.
ARM B: Patients and their support persons undergo the usual care over 8 weeks.
- Conditions
- Extensive Stage Small Cell Lung Cancer, Healthy, no Evidence of Disease, Limited Stage Small Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Recurrent Small Cell Lung Cancer, Stage IA Non-small Cell Lung Cancer
- Being tested
- exercise intervention, standard follow-up care, quality-of-life assessment, laboratory biomarker analysis
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise interventionBehavioural
Receive aerobic and exercise intervention
standard follow-up careProcedure or surgery
Receive usual care
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm A (aerobic and exercise training) | Experimental | Patients and their support persons undergo a supervised combined aerobic exercise comprising walking, cycling, or video-based aerobics and strength training using resistance bands for 40 minutes 2 days a week at the UWHC and 3 days a week at home over 8 weeks. Receives: Behavioral: exercise intervention; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis |
| Arm II (usual care) | Active comparator | Patients and their support persons undergo the usual care over 8 weeks. Receives: Procedure: standard follow-up care; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in biomarkers of inflammation
Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time.
Measured: Baseline up to 8 weeks
Change in oxidative damage as indicated by serum 8-hydroxydeoxyguanosine (8-oh-dG)
Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time.
Measured: Baseline up to 8 weeks
Change in time to walk 400 m
Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time.
Measured: Baseline up to 8 weeks
Change in physical well-being scores on the Functional Assessment of Cancer Therapy-Lung (FACT-L)
Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time.
Measured: Baseline up to 8 weeks
Change in functional well-being scores on the FACT-L
Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time.
Measured: Baseline up to 8 weeks
Secondary outcomes (2)
Change in stress scores on the SF-36
Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time.
Measured: Baseline up to 8 weeks
Change in quality-of-life scores on the SF-36
Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time.
Measured: Baseline up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJul 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive Stage Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Toby Campbell, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01999881
- Sponsor's protocol ID
- UW13034
- Other IDs
- NCI-2013-02185, 2013-0752, UW13034, P30CA014520, A534260, SMPH\MEDICINE\HEM-ONC
- Status last verified
- Feb 2016
- First submitted
- 25 Nov 2013
- Last updated
- 18 Nov 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacts of Exercise on Prognostic Biomarkers in Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT01999881
- Acronym / sponsor ID
- UW13034
- Conditions
- Extensive Stage Small Cell Lung Cancer, Healthy, no Evidence of Disease, Limited Stage Small Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Recurrent Small Cell Lung Cancer, Stage IA Non-small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 3 Dec 2013 (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.
This randomized pilot clinical trial studies exercise intervention in improving quality of life and exercise capacity and reducing inflammation and oxidative stress in patients with lung cancer and their support persons. Exercise therapy may help improve quality of life, may increase exercise capacity, and may reduce inflammation and oxidative stress in patients with lung cancer and their supporters.
Detailed description
PRIMARY OBJECTIVES:
- Determine the effect of an eight-week exercise intervention on biomarkers of inflammation, oxidative stress, exercise capacity, and quality of life in lung cancer patients.
SECONDARY OBJECTIVES:
- Determine the effect of an eight-week exercise intervention on markers of stress and quality of life in the support person of lung cancer patients.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM A: Patients and their support persons undergo a supervised combined aerobic exercise comprising walking, cycling, or video-based aerobics and strength training using resistance bands for 40 minutes 2 days a week at the University of Wisconsin Hospital and Clinic (UWHC) and 3 days a week at home over 8 weeks.
ARM B: Patients and their support persons undergo the usual care over 8 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (aerobic and exercise training) | Experimental | Behavioral: exercise intervention, Procedure: quality-of-life assessment, Other: laboratory biomarker analysisPatients and their support persons undergo a supervised combined aerobic exercise comprising walking, cycling, or video-based aerobics and strength training using resistance bands for 40 minutes 2 days a week at the UWHC and 3 days a week at home over 8 weeks. |
| Arm II (usual care) | Active comparator | Procedure: standard follow-up care, Procedure: quality-of-life assessment, Other: laboratory biomarker analysisPatients and their support persons undergo the usual care over 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- LUNG CANCER PATIENTS: A confirmed diagnosis of any stage lung cancer (non-small cell lung cancer [NSCLC] or small cell lung cancer [SCLC])
- LUNG CANCER PATIENTS: Can be receiving any type of treatment (chemotherapy, radiation therapy, both or neither) are eligible
- LUNG CANCER PATIENTS: Able to understand and read in English sufficiently to adequately complete informed consent to participate and to complete the questionnaires
- LUNG CANCER PATIENTS: For patients treated with curative intent, and who have not relapsed, they must be within 1 year of their diagnosis of lung cancer (determined by date of diagnostic pathology sample)
- SUPPORT PERSONS: Able to understand and read in English sufficiently to adequately complete informed consent to participate and to complete the questionnaires
Key exclusion criteria (9 listed)
- LUNG CANCER PATIENTS: Symptomatic heart disease including congestive heart failure or arrhythmia
- LUNG CANCER PATIENTS: Documented myocardial infarction in the last three months
- LUNG CANCER PATIENTS: Central nervous system (CNS) metastases that results in impaired ability to participate in an exercise program at the discretion of the study physician
- LUNG CANCER PATIENTS: Any psychological or physical disease that would impair or prevent participation in an exercise program at the discretion of the study physician
- LUNG CANCER PATIENTS: Cognitive or reading impairments that would preclude them from completing questionnaires
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 interventionReceive aerobic and exercise intervention | Behavioural | Arm A (aerobic and exercise training) |
| standard follow-up careReceive usual care | Procedure or surgery | Arm II (usual care) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Arm A (aerobic and exercise training), Arm II (usual care) |
| laboratory biomarker analysisCorrelative studies | Other | Arm A (aerobic and exercise training), Arm II (usual care) |
Primary outcome
Change in biomarkers of inflammation
Time frame: Baseline up to 8 weeks
Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time.
Change in oxidative damage as indicated by serum 8-hydroxydeoxyguanosine (8-oh-dG)
Time frame: Baseline up to 8 weeks
Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time.
Change in time to walk 400 m
Time frame: Baseline up to 8 weeks
Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time.
Change in physical well-being scores on the Functional Assessment of Cancer Therapy-Lung (FACT-L)
Time frame: Baseline up to 8 weeks
Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time.
Change in functional well-being scores on the FACT-L
Time frame: Baseline up to 8 weeks
Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time.
2 secondary outcomes
Change in stress scores on the SF-36
Time frame: Baseline up to 8 weeks
Change in quality-of-life scores on the SF-36
Time frame: Baseline up to 8 weeks
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 18 Nov 2019.
- University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
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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.
Toby Campbell principal investigator
University of Wisconsin, Madison
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise intervention, standard follow-up care and quality-of-life assessment in people with Extensive Stage Small Cell Lung Cancer and Healthy, no Evidence of Disease, run by University of Wisconsin, Madison at 2 sites in United States.
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 5 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 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 biomarkers of inflammation (time frame: Baseline up to 8 weeks). The study lists 5 primary outcomes in all. 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 18 Nov 2019.