Is NeuroMuscular Electrical Stimulation an acceptable and feasible supportive therapy for patients with non-small cell lung cancer receiving palliative chemotherapy?

Is NeuroMuscular Electrical Stimulation an acceptable and feasible supportive therapy for patients with non-small cell lung cancer receiving palliative chemotherapy?: an open randomised phase II trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN42944026

Enrollment

Registered

2008-12-11

Start date

2009-02-01

Completion date

Unknown

Last updated

2022-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer Cancer Malignant neoplasm of bronchus and lung

Interventions

Participants will be randomly allocated (1:1 allocation ratio) to receive one of the following treatment regimen(s): Control arm: Three to four cycles of first line palliative chemoth

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Both males and females, 16 years or over 2. Informed consent 3. Histological diagnosis of NSCLC 4. Eastern Collaborative Oncology Group (ECOG) Performance Status of 0, 1 or 2 5. Scheduled to receive 3-4 cycles of first line palliative chemotherapy with carboplatin/vinorelbine

Exclusion criteria

Exclusion criteria: 1. Implanted cardiac pacemaker 2. Epilepsy 3. Spinal cord pathology 4. Pregnancy

Design outcomes

Primary

Measure	Time frame
Adherence to NMES: Proportion of patients completing a pre-determined level of compliance to the recommended NMES programme (NMES for 30 min three times a week) measured using a self-report daily diary. The primary and secondary outcomes will be assessed at baseline, end of treatment at week 9 or 12 (depending on 3 or 4 chemotherapy cycles), follow-up assessments at week 17 or 20 (depending on 3 or 4 chemotherapy cycles).	—

Measure

Time frame

Adherence to NMES: Proportion of patients completing a pre-determined level of compliance to the recommended NMES programme (NMES for 30 min three times a week) measured using a self-report daily diary. The primary and secondary outcomes will be assessed at baseline, end of treatment at week 9 or 12 (depending on 3 or 4 chemotherapy cycles), follow-up assessments at week 17 or 20 (depending on 3 or 4 chemotherapy cycles).

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Secondary

Measure	Time frame
1. Safety of NMES: real-time adverse event reporting using the Common Terminology Criteria for Adverse Events (CTC AE) v3.0 2. Quadriceps muscle strength: peak torque (Nm) measured using a portable Manual Muscle Tester® dynamometer (Lafayette Instruments, USA) 3. Body composition: lean tissue mass of the body and thighs (kg) assessed by low-dose dual energy x-ray absorptiometry (DEXA) 4. Physical activity level: mean daily step count assessed by a small, lightweight activPAL™ accelerometer worn on the thigh for one week 5. Response to chemotherapy: overall objective clinical response categorised using Response Evaluation Criteria In Solid Tumours, documented from patients' medical reports 6. Nutritional intake: mean daily energy (kJ/d) and protein (g/d) intake estimated from a 3-day food and drink diary 7. Fatigue: Multidimensional Fatigue Inventory 8. Quality of life: the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30) and the lung cancer specific module EORTC QLQ-LC13 The primary and secondary outcomes will be assessed at baseline, end of treatment at week 9 or 12 (depending on 3 or 4 chemotherapy cycles), follow-up assessments at week 17 or 20 (depending on 3 or 4 chemotherapy cycles).	—

Measure

Time frame

1. Safety of NMES: real-time adverse event reporting using the Common Terminology Criteria for Adverse Events (CTC AE) v3.0 2. Quadriceps muscle strength: peak torque (Nm) measured using a portable Manual Muscle Tester® dynamometer (Lafayette Instruments, USA) 3. Body composition: lean tissue mass of the body and thighs (kg) assessed by low-dose dual energy x-ray absorptiometry (DEXA) 4. Physical activity level: mean daily step count assessed by a small, lightweight activPAL™ accelerometer worn on the thigh for one week 5. Response to chemotherapy: overall objective clinical response categorised using Response Evaluation Criteria In Solid Tumours, documented from patients' medical reports 6. Nutritional intake: mean daily energy (kJ/d) and protein (g/d) intake estimated from a 3-day food and drink diary 7. Fatigue: Multidimensional Fatigue Inventory 8. Quality of life: the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30) and the lung cancer specific module EORTC QLQ-LC13 The primary and secondary outcomes will be assessed at baseline, end of treatment at week 9 or 12 (depending on 3 or 4 chemotherapy cycles), follow-up assessments at week 17 or 20 (depending on 3 or 4 chemotherapy cycles).

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Countries

United Kingdom, Wales

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 9, 2026