First-Line Chemotherapy With or Without Neuromuscular Electrical Stimulation in Treating Patients With Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as carboplatin and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemotherapy can lead to a loss of leg muscle strength. Neuromuscular electrical stimulation may improve muscle strength and quality of life. It is not yet known whether chemotherapy given together with neuromuscular electrical stimulation is more effective than chemotherapy alone in treating patients with non-small cell lung cancer. PURPOSE: This randomized phase II trial is studying first-line chemotherapy given together with neuromuscular electrical stimulation to see how well it works compared with chemotherapy alone in treating patients with non-small cell lung cancer.

Detailed Description
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OBJECTIVES: Primary To determine the feasibility of first-line palliative chemotherapy alone versus palliative chemotherapy in combination with neuromuscular electrical stimulation (NMES) in patients with non-small cell lung cancer. Secondary To determine if NMES is safe for patients undergoing palliative chemotherapy. To determine to what extent 3 or 4 courses of palliative chemotherapy impact leg muscle strength, body composition, and physical activity levels and if the use of NMES influence these changes. To determine the rate of recovery or decline in leg muscle strength, body composition, and physical activity levels following completion of 3 or 4 courses of palliative chemotherapy and if the use of NMES influences these changes. To assess patient attitudes to the use of NMES during palliative chemotherapy. OUTLINE: Patients are randomized to 1 of 2 treatment arms. Arm I (control): Patients receive first-line palliative chemotherapy comprising carboplatin and vinorelbine in weeks 1, 4, 7, and 10 as part of usual care at Nottingham University Hospital National Health Service Trust. Arm II (experimental): Patients receive chemotherapy as in arm I. Patients also undergo, at home, neuromuscular electrical stimulation (NMES) in weeks 2-12 (to the anterior thighs) 3 times a week for 30 minutes. NMES treatment increases in duration on a weekly basis from 11% to 18% to 25%, and then remaining constant thereafter. All patients undergo assessment of quadriceps muscle strength, body composition, physical activity level, nutritional intake, and fatigue at baseline and week 9, and week 17 or 20. Patients complete quality-of-life questionnaires (EORTC-C30 and LC-13) at baseline, at week 9, and at week 17 or 20. After completion of study treatment, patients are followed up for 8 weeks.

Official Title
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NMES for Patients With NSCLC Receiving Palliative Chemotherapy. Is Neuromuscular Electrical Stimulation an Acceptable and Feasible Supportive Therapy for Patients With Non-Small Cell Lung Cancer Receiving Palliative Chemotherapy?

Conditions
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Chemotherapeutic Agent Toxicity, Fatigue, Lung Cancer, Musculoskeletal Complications

Intervention / Treatment
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* Drug: carboplatin
* Drug: vinorelbine tartrate
* Other: neuromuscular electrical stimulation
* Other: physiologic testing
* Procedure: fatigue assessment and management
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed non-small cell lung cancer Scheduled to receive 3 or 4 courses of first-line palliative chemotherapy PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy > 3 months Not pregnant or nursing Able to use neuromuscular electrical stimulation device No implanted cardiac pacemaker No epilepsy No spinal cord pathology PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: carboplatin|nan|
|Drug: vinorelbine tartrate|nan|
|Other: neuromuscular electrical stimulation|nan|
|Other: physiologic testing|nan|
|Procedure: fatigue assessment and management|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to neuromuscular electrical stimulation (NMES) therapy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of NMES |  |  | 
| Quadriceps muscle strength |  |  | 
| Body composition |  |  | 
| Physical activity level |  |  | 
| Nutritional intake |  |  | 
| Fatigue |  |  | 
| Quality of life using the EORTC-C30 and LC-13 questionnaire |  |  | 
| Overall objective clinical response to chemotherapy |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemotherapeutic agent toxicity, musculoskeletal complications, fatigue, stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer