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

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?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01097317
• Other study ID #: CDR0000669234
• Secondary ID: WCTU-NMESISRCTN-
• Status: Recruiting
• Phase: Phase 2
• First received: March 31, 2010
• Last updated: August 5, 2011
• Start date: September 2009

Study information

• Verified date: September 2010
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• 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

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Chemotherapeutic Agent Toxicity
• Fatigue
• Lung Cancer
• Lung Neoplasms
• Musculoskeletal Complications

Intervention

Drug:
• carboplatin

• vinorelbine tartrate

Other:
• neuromuscular electrical stimulation

• physiologic testing

Procedure:
• fatigue assessment and management

• quality-of-life assessment

Locations

Country	Name	City	State
United Kingdom	Nottingham City Hospital	Nottingham	England

Sponsors (1)

Lead Sponsor	Collaborator
Wales Cancer Trials Unit

Country where clinical trial is conducted

United Kingdom, 

Outcome

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