First-Line Chemotherapy With or Without Neuromuscular Electrical Stimulation in Treating Patients With Non-Small Cell Lung Cancer
Conditions
Chemotherapeutic Agent Toxicity - Fatigue - Lung Cancer - Musculoskeletal Complications
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
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
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
Intervention
Name: carboplatin Type: Drug
Name: vinorelbine tartrate Type: Drug
Name: neuromuscular electrical stimulation Type: Other
Name: physiologic testing Type: Other
Name: fatigue assessment and management Type: Procedure
Name: quality-of-life assessment Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 16 Years
Gender: Both
Criteria: 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
Location
Nottingham City Hospital
Nottingham, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-115-9627-778 - Andrew.Wilcock@nottingham.ac.uk
Start Date
September 2009
Sponsors
Wales Cancer Trials Unit
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page