Back to resultsResistance Training in Lung Cancer Patients on Chemotherapy
Primary Purpose
Inflammation, Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Inflammation focused on measuring inflammation, chemotherapy, lung cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically diagnosed with lung cancer
- Stage I, II, or III
- Eligible for chemotherapy with curative intent
- 21 years of age or older
- Approval to participate in study by treating oncologist or family physician
Exclusion Criteria:
- Unstable cardiac disease
- Untreated bone or brain metastases
Sites / Locations
- Leo Jenkins Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Resistance training
Control
Arm Description
Group assigned to complete resistance training during duration of chemotherapy.
Usual care.
Outcomes
Primary Outcome Measures
Systemic inflammation measured by c-reactive protein.
Secondary Outcome Measures
Chemotherapy completion
Full Information
NCT ID
NCT01130714
First Posted
January 6, 2010
Last Updated
August 19, 2015
Sponsor
East Carolina University
1. Study Identification
Unique Protocol Identification Number
NCT01130714
Brief Title
Resistance Training in Lung Cancer Patients on Chemotherapy
Official Title
Effectiveness of a Resistance Training Program on Inflammatory Markers and Chemotherapy Completion in Lung Cancer Patients on Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
East Carolina University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to examine the effectiveness of a resistance training program on reducing systemic inflammation and improving chemotherapy completion in lung cancer patients being treated with curative intent chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Lung Cancer
Keywords
inflammation, chemotherapy, lung cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resistance training
Arm Type
Experimental
Arm Description
Group assigned to complete resistance training during duration of chemotherapy.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Resistance training with resistance bands.
Primary Outcome Measure Information:
Title
Systemic inflammation measured by c-reactive protein.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Chemotherapy completion
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically diagnosed with lung cancer
Stage I, II, or III
Eligible for chemotherapy with curative intent
21 years of age or older
Approval to participate in study by treating oncologist or family physician
Exclusion Criteria:
Unstable cardiac disease
Untreated bone or brain metastases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristina H Karvinen, PhD
Organizational Affiliation
East Carolina University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leo Jenkins Cancer Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24683529
Citation
Karvinen KH, Esposito D, Raedeke TD, Vick J, Walker PR. Effect of an exercise training intervention with resistance bands on blood cell counts during chemotherapy for lung cancer: a pilot randomized controlled trial. Springerplus. 2014 Jan 8;3:15. doi: 10.1186/2193-1801-3-15. eCollection 2014.
Results Reference
derived
Learn more about this trial
Resistance Training in Lung Cancer Patients on Chemotherapy
We'll reach out to this number within 24 hrs