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- Ensaio 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
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Virginia
-
Richmond, Virginia, Estados Unidos, 23298
- Virginia Commonwealth University
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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
Outros nomes:
Brief Pain Inventory questionnaire administration at baseline, weekly, then monthly for 3 months
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Pain Score From Day 1 to Day 10
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Effect of Electrical Stimulation Pain Therapy on Other Non-pain Symptoms at Day 1
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- MCC-13098
- NCI-2010-01945 (Identificador de registro: CTRP)
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