Lung Cancer Clinical Trial
Official title:
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?
Verified date | September 2010 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | Unspecified |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 52 |
Est. completion date | |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
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 |
Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United Kingdom | Nottingham City Hospital | Nottingham | England |
Lead Sponsor | Collaborator |
---|---|
Wales Cancer Trials Unit |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adherence to neuromuscular electrical stimulation (NMES) therapy | No | ||
Secondary | Safety of NMES | Yes | ||
Secondary | Quadriceps muscle strength | No | ||
Secondary | Body composition | No | ||
Secondary | Physical activity level | No | ||
Secondary | Nutritional intake | No | ||
Secondary | Fatigue | No | ||
Secondary | Quality of life using the EORTC-C30 and LC-13 questionnaire | No | ||
Secondary | Overall objective clinical response to chemotherapy | No |
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