- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01196442
Electrical Stimulation Pain Therapy in Treating Chronic Pain and Numbness Caused By Chemotherapy in Patients With Cancer
An Expanded Trial of MC5-A Calmare Therapy in the Treatment of Cancer Pain Syndromes and Chronic Chemotherapy-Induced Peripheral Neuropathy Including Pain and Numbness
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
I. To evaluate the effect of MC5-A on pain symptoms both immediately and over time.
II. To evaluate the effect of Calmare therapy on other non-pain symptoms. III. To evaluate the effect of MC5-A on daily opioid and other pain medication use.
OUTLINE: Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days. After completion of study treatment, patients are followed up for 3 months.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Virginia
-
Richmond, Virginia, Estados Unidos, 23298
- Virginia Commonwealth University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- CIPN neuropathy: received, or currently receiving, neurotoxic chemotherapy (including taxanes-such as paclitaxel or docetaxel, or platinum-based compounds such as carboplatin or cis-platinum or oxaliplatin, or vinca alkaloids such as vincristine, vinblastine, or vinorelbine, or proteosome inhibitors such as bortezomib)
- Pain or symptoms of peripheral neuropathy of >= 1 months duration attributed to chemotherapy-induced peripheral neuropathy
- OR pain of the other types including chemotherapy-induced peripheral neuropathy, numbness predominant; post mastectomy pain; post surgical pain; post herpetic neuropathy; post radiation pain; other (vertebral compression, fracture, miscellaneous)
- The pain must have been stable for at least 2 weeks
- An average daily pain rating of >= 5 out of 10, using the pain numerical rating scale (NRS: 0 is no pain and 10 is worst pain possible); or numbness that bothers the patient at least "a little bit" on the CIPN-20
- Life expectancy >= 3 months
- ECOG performance status 0, 1, or 2
Exclusion Criteria:
- Pregnant women, nursing women, women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, abstinence, etc.)
- Use of an investigational agent for pain control concurrently or =< 30 days
- History of an allergic reaction or previous intolerance to transcutaneous electronic nerve stimulation
- Patients with implantable drug delivery systems, e.g., Medtronic Synchromed
- Patients with heart stents or metal implants such as pacemakers, automatic defibrillators, aneurysm clips, vena cava clips and skull plates (metal implants for orthopedic repair, e.g., pins, clips, plates, cages, joint replacements are allowed)
- Patients with a history of myocardial infarction or ischemic heart disease within the past six months
- Patients with history of epilepsy, brain damage, use of anti-convulsants, symptomatic brain metastases
- Prior celiac plexus block, or other neurolytic pain control treatment within 4 weeks
- Other identified causes of painful paresthesias existing prior to chemotherapy (e.g., radiation or malignant plexopathy, lumbar or cervical radiculopathy, pre-existing peripheral neuropathy of another etiology: B12 deficiency, AIDS, monoclonal gammopathy, diabetes, heavy metal poisoning amyloidosis, syphilis, hyperthyroidism or hypothyroidism, inherited neuropathy)
- Skin conditions such as open sores that would prevent proper application of the electrodes
- Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Arm I electric stimulation pain therapy
Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.
|
Electrical stimulation pain therapy for 45 minutes on Day 1, then 30 minutes Days 2-10
Otros nombres:
Brief Pain Inventory questionnaire administration at baseline, weekly, then monthly for 3 months
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Pain Score From Day 1 to Day 10
Periodo de tiempo: From day 1 to day 10
|
Change in Brief Pain Inventory (Now)Scale 1 (none) to 5 (complete interference) |
From day 1 to day 10
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Effect of Electrical Stimulation Pain Therapy on Other Non-pain Symptoms at Day 1
Periodo de tiempo: Day 1
|
Chemotherapy-induced peripheral neuropathy (CIPN)-20.
The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale.
There are 17 questions that are rated 0-not at all to 3-very much.
Scales are summed.
Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.
|
Day 1
|
|
Use of Medications Including Morphine Oral Dose Equivalents, Anti-depressants, and Neuroleptics
Periodo de tiempo: From day 1 to day 30
|
Record daily pain medication usage and convert all opioids to MOEDs (American Pain Society 2003).
Compare the average daily use prior to day 1 to the average daily use day 30.
Range is 0-none to 240-most
|
From day 1 to day 30
|
|
Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Day 10
Periodo de tiempo: Day 10
|
Chemotherapy-induced peripheral neuropathy (CIPN)-20.
The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale.
There are 17 questions that are rated 0-not at all to 3-very much.
Scales are summed.
Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.
|
Day 10
|
|
Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 1
Periodo de tiempo: month 1
|
Chemotherapy-induced peripheral neuropathy (CIPN)-20.
The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale.
There are 17 questions that are rated 0-not at all to 3-very much.
Scales are summed.
Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.
|
month 1
|
|
Effect of Electric Stimulation Pain Therapy n Other Non-pain Symptoms at Month 2
Periodo de tiempo: month 2
|
Chemotherapy-induced peripheral neuropathy (CIPN)-20.
The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale.
There are 17 questions that are rated 0-not at all to 3-very much.
Scales are summed.
Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.
|
month 2
|
|
Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 3
Periodo de tiempo: Month 3
|
Chemotherapy-induced peripheral neuropathy (CIPN)-20.
The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale.
There are 17 questions that are rated 0-not at all to 3-very much.
Scales are summed.
Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.
|
Month 3
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Craig Swainey, MD, Virginia Commonwealth University
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MCC-13098
- NCI-2010-01945 (Identificador de registro: CTRP)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .