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

NCT01097317 | Unknown Phase 2

• 5 other identifiers: CDR0000669234WCTU-NMESISRCTN-42944026EU-21019NCRI-LCSUPAC-35
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapeutic Agent Toxicity; Fatigue; Lung Cancer; Musculoskeletal Complications

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

Outcome Measures

Primary Outcomes (1)

• Adherence to neuromuscular electrical stimulation (NMES) therapy

Secondary Outcomes (8)

• Safety of NMES

• Quadriceps muscle strength

• Body composition

• Physical activity level

• Nutritional intake

Interventions

carboplatin DRUG

vinorelbine tartrate DRUG

neuromuscular electrical stimulation OTHER

physiologic testing OTHER

fatigue assessment and management PROCEDURE

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Wales Cancer Trials Unit: lead

Study Sites (1)

Nottingham City Hospital

Nottingham, England, NG5 1PB, United Kingdom

RECRUITING

MeSH Terms

Conditions

Fatigue; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Vinorelbine; Therapeutics

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Andrew Wilcock, MD

  Nottingham City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 31, 2010
• First Posted: April 1, 2010
• Study Start: September 1, 2009
• Primary Completion: September 1, 2011
• Last Updated: August 8, 2011

Record last verified: 2010-09

Locations

GB (1)