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

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ClinicalTrials.gov Identifier: NCT01097317
Recruitment Status : Unknown
Verified September 2010 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : April 1, 2010
Last Update Posted : August 8, 2011
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment Phase
Chemotherapeutic Agent Toxicity Fatigue Lung Cancer Musculoskeletal Complications Drug: carboplatin Drug: vinorelbine tartrate Other: neuromuscular electrical stimulation Other: physiologic testing Procedure: fatigue assessment and management Procedure: quality-of-life assessment Phase 2

Detailed 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Supportive Care
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?
Study Start Date : September 2009
Estimated Primary Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Adherence to neuromuscular electrical stimulation (NMES) therapy

Secondary Outcome Measures :
  1. Safety of NMES
  2. Quadriceps muscle strength
  3. Body composition
  4. Physical activity level
  5. Nutritional intake
  6. Fatigue
  7. Quality of life using the EORTC-C30 and LC-13 questionnaire
  8. Overall objective clinical response to chemotherapy

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01097317


Locations
United Kingdom
Nottingham City Hospital Recruiting
Nottingham, England, United Kingdom, NG5 1PB
Contact: Contact Person    44-115-9627-778    Andrew.Wilcock@nottingham.ac.uk   
Sponsors and Collaborators
Wales Cancer Trials Unit
Investigators
Principal Investigator: Andrew Wilcock, MD Nottingham City Hospital
More Information

ClinicalTrials.gov Identifier: NCT01097317     History of Changes
Other Study ID Numbers: CDR0000669234
WCTU-NMES
ISRCTN-42944026
EU-21019
NCRI-LCSUPAC-35
First Posted: April 1, 2010    Key Record Dates
Last Update Posted: August 8, 2011
Last Verified: September 2010

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Fatigue
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Signs and Symptoms
Vinorelbine
Carboplatin
Antineoplastic Agents
Antineoplastic Agents, Phytogenic