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?
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.
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.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03918538 -
A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors
|
N/A | |
Recruiting |
NCT05078918 -
Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors
|
N/A | |
Active, not recruiting |
NCT04548830 -
Safety of Lung Cryobiopsy in People With Cancer
|
Phase 2 | |
Completed |
NCT04633850 -
Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
|
||
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT05583916 -
Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery
|
N/A | |
Completed |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Not yet recruiting |
NCT06376253 -
A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers
|
Phase 1 | |
Recruiting |
NCT05898594 -
Lung Cancer Screening in High-risk Black Women
|
N/A | |
Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03575793 -
A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
Terminated |
NCT01624090 -
Mithramycin for Lung, Esophagus, and Other Chest Cancers
|
Phase 2 | |
Terminated |
NCT03275688 -
NanoSpectrometer Biomarker Discovery and Confirmation Study
|
||
Not yet recruiting |
NCT04931420 -
Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels
|
Phase 2 | |
Recruiting |
NCT06010862 -
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
|
Phase 1 | |
Recruiting |
NCT06052449 -
Assessing Social Determinants of Health to Increase Cancer Screening
|
N/A | |
Not yet recruiting |
NCT06017271 -
Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
|
||
Recruiting |
NCT05787522 -
Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk
|