NCT01999881

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

November 25, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

November 18, 2019

Status Verified

February 1, 2016

Enrollment Period

1.6 years

First QC Date

November 25, 2013

Last Update Submit

November 14, 2019

Conditions

Extensive Stage Small Cell Lung CancerHealthy, no Evidence of DiseaseLimited Stage Small Cell Lung CancerRecurrent Non-small Cell Lung CancerRecurrent Small Cell Lung CancerStage IA Non-small Cell Lung CancerStage IB Non-small Cell Lung CancerStage IIA Non-small Cell Lung CancerStage IIB Non-small Cell Lung CancerStage IIIA Non-small Cell Lung CancerStage IIIB Non-small Cell Lung CancerStage IV Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    Baseline up to 8 weeks

Secondary Outcomes (2)

  • Change in stress scores on the SF-36

    Baseline up to 8 weeks

  • Change in quality-of-life scores on the SF-36

    Baseline up to 8 weeks

Study Arms (2)

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.

Behavioral: exercise interventionProcedure: quality-of-life assessmentOther: laboratory biomarker analysis

Arm II (usual care)

ACTIVE COMPARATOR

Patients and their support persons undergo the usual care over 8 weeks.

Procedure: standard follow-up careProcedure: quality-of-life assessmentOther: laboratory biomarker analysis

Interventions

exercise interventionBEHAVIORAL

Receive aerobic and exercise intervention

Arm A (aerobic and exercise training)
standard follow-up carePROCEDURE

Receive usual care

Arm II (usual care)
quality-of-life assessmentPROCEDURE

Ancillary studies

Also known as: quality of life assessment
Arm A (aerobic and exercise training)Arm II (usual care)
laboratory biomarker analysisOTHER

Correlative studies

Arm A (aerobic and exercise training)Arm II (usual care)

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UW Health Oncology - 1 South Park

Madison, Wisconsin, 53715, United States

Location

University of Wisconsin, Madison

Madison, Wisconsin, 53792, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Toby Campbell

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 25, 2013

First Posted

December 3, 2013

Study Start

December 1, 2013

Primary Completion

July 1, 2015

Study Completion

February 1, 2016

Last Updated

November 18, 2019

Record last verified: 2016-02

Locations

US(2)