First-Line Chemotherapy With or Without Neuromuscular Electrical Stimulation in Treating Patients With Non-Small Cell Lung Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Wales Cancer Trials Unit
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01097317
First received: March 31, 2010
Last updated: August 5, 2011
Last verified: September 2010
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Purpose
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 | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: 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? |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Adherence to neuromuscular electrical stimulation (NMES) therapy [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety of NMES [ Designated as safety issue: Yes ]
- Quadriceps muscle strength [ Designated as safety issue: No ]
- Body composition [ Designated as safety issue: No ]
- Physical activity level [ Designated as safety issue: No ]
- Nutritional intake [ Designated as safety issue: No ]
- Fatigue [ Designated as safety issue: No ]
- Quality of life using the EORTC-C30 and LC-13 questionnaire [ Designated as safety issue: No ]
- Overall objective clinical response to chemotherapy [ Designated as safety issue: No ]
| Estimated Enrollment: | 52 |
| Study Start Date: | September 2009 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT01097317 History of Changes |
| Other Study ID Numbers: | CDR0000669234, WCTU-NMES, ISRCTN-42944026, EU-21019, NCRI-LCSUPAC-35 |
| Study First Received: | March 31, 2010 |
| Last Updated: | August 5, 2011 |
| Health Authority: | Unspecified |
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:
|
Carcinoma, Non-Small-Cell Lung Fatigue Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Signs and Symptoms |
Vinorelbine Vinblastine Carboplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013