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

Phase 2

• Conditions: Chemotherapeutic Agent Toxicity; Fatigue; Lung Cancer; Musculoskeletal Complications

• Registration Number: NCT01097317
• Lead Sponsor: Wales Cancer Trials Unit

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-03-31
• Study First Submitted QC: 2010-03-31
• Study First Posted: 2010-04-01
• Status Verified: 2010-09
• Last Update Submitted: 2011-08-05
• Last Update Posted: 2011-08-08
• Primary Completion: 2011-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adherence to neuromuscular electrical stimulation (NMES) therapy

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nottingham City Hospital; 🇬🇧 Nottingham, England, United Kingdom