Trial Information

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?

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.