Effects of VNS on RT-induced Inflammation and Prognosis of Patients With NSCLC
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ClinicalTrials.gov Identifier: NCT03553485 |
Recruitment Status :
Recruiting
First Posted : June 12, 2018
Last Update Posted : June 25, 2019
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Tracking Information | |||||
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First Submitted Date ICMJE | May 11, 2018 | ||||
First Posted Date ICMJE | June 12, 2018 | ||||
Last Update Posted Date | June 25, 2019 | ||||
Actual Study Start Date ICMJE | August 8, 2018 | ||||
Estimated Primary Completion Date | October 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT03553485 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Health related Quality of Life [ Time Frame: 7 weeks ] To assess the psychological well-being and quality of life of the patients during their radiotherapy treatment the EORTC QLQ-C30 questionnaire will be used.
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Original Secondary Outcome Measures ICMJE |
Quality of Life [ Time Frame: 7 weeks ] To assess the psychological well-being and quality of life of the patients during their radiotherapy treatment the EORTC QLQ-C30 questionnaire will be used.
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Effects of VNS on RT-induced Inflammation and Prognosis of Patients With NSCLC | ||||
Official Title ICMJE | Effects of Transcutaneous Auricular Vagal Nerve Stimulation on Radiotherapy-induced Inflammation and Prognosis of Patients With Lung Cancer | ||||
Brief Summary | Lung cancer (LC) remains a leading cause of death among cancers worldwide. Though radiotherapy is one of the most frequently used treatments, it increases side-effects (pain, fatigue) and inflammation, possibly leading to further tumorigenesis of surviving cancer cells. The purpose of this study is to test the effects of transcutaneous auricular VNS vagal nerve stimulation (taVNS), known to reduce inflammation, on radiotherapy-induced inflammation and other side-effects in LC patients undergoing radiotherapy. In this feasibility study 12 patients with NSCLC stage III (A/B) receiving radiotherapy will be enrolled. Our primary endpoint is the effect of vagus nerve stimulation (VNS) on inflammatory levels (such as CRP and cytokines), immunological factors (neutrophils, monocytes, lymphocytes) and the tumor marker CEA. Our secondary endpoint is the psychological well-being and quality of life of the patients during their radiotherapy treatment. |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Lung Cancer, Non-small Cell | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
12 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 2019 | ||||
Estimated Primary Completion Date | October 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Belgium | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03553485 | ||||
Other Study ID Numbers ICMJE | 1.0_09/01/2018 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Reijmen Eva, Vrije Universiteit Brussel | ||||
Study Sponsor ICMJE | Vrije Universiteit Brussel | ||||
Collaborators ICMJE | Kom Op Tegen Kanker | ||||
Investigators ICMJE |
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PRS Account | Vrije Universiteit Brussel | ||||
Verification Date | June 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |