Manejo da dor e da carga de sintomas causada pela quimioterapia em pessoas com mieloma ou linfoma
Tratamento da dor poupador de opioides em pacientes com mieloma e linfoma submetidos a quimioterapia de alta dose (OPTIMAL-HiChemo): estudo controlado randomizado
The purpose of this study is to find out whether acupuncture treatments can reduce the need for opioid medication when managing pain caused by chemotherapy. The study will compare the effects of adding acupuncture to usual pain management with those of usual pain management alone, in reducing opioid use by relieving pain. Researchers also want to find out more about the effects of acupuncture treatments on other symptoms caused by cancer treatments and quality of life.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
-
-
New York
-
New York, New York, Estados Unidos, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Washington
-
Seattle, Washington, Estados Unidos, 98109
- Seattle Cancel Care Alliance (Data Collection Only)
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- age 18 or older
- pathological diagnosis of MM, HD or NHL
- scheduled for high dose chemotherapy for auto-HSCT in the following month (30 days)
- not taking opioids regularly in the week prior to consent (one-time dosing of opioids for a painful procedure is allowed)
Exclusion Criteria:
- absolute neutrophil count (ANC) of <500/μl, platelet count of <20,000/ μl or INR >2.0
- acupuncture within two weeks prior to HiChemo (to avoid residual effects of acupuncture)
- unable to provide informed consent
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Usual Care plus Acupuncture
Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. to prevent severe pain. If acupuncture does not prevent severe pain, the participant will receive opioid medication as backup pain relief. |
Acupuncture treatments will be scheduled to cover the period of high symptom burden. Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. Electrical stimulation (e-acupuncture) may be applied to the ST36 and SP6 points when appropriate as per standard acupuncture practice. All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo. |
|
Comparador Ativo: Usual Care
Will receive only the usual pain management approach, which includes opioid medication when needed for severe pain, according to the routine guidelines for their care. |
All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
the Number of Patients Using Opioids at a Given Time
Prazo: at day 7
|
at a given time divided by the total number of patients randomized to that group at Day 7) by review of medication records and urine drug test |
at day 7
|
|
the Number of Patients Using Opioids at a Given Time
Prazo: at day 90
|
at a given time divided by the total number of patients randomized to that group at Day 90) by review of medication records and urine drug test |
at day 90
|
|
Symptom Burden
Prazo: At baseline
|
measured by M. D. Anderson Symptom Inventory Blood and Marrow Transplantaion (MDASI-BMT). The symptoms rated are feeling physically sick, weak, diarrhea, mouth sores, and bleeding. All symptoms are rated with reference to "the last 24 hours" on 0-10 numeric scales from "not present" to "as bad as you can imagine." MDASIBMT Total Symptom Severity score will serve as the symptom burden primary endpoint. The MDASI assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 numerical scale with 0 being "not present" and 10 being "as bad as you can imagine. Total symptom severity was calculated by averaging all 18 items in the scale |
At baseline
|
|
Symptom Burden
Prazo: At Day 7
|
measured by M. D. Anderson Symptom Inventory Blood and Marrow Transplantaion (MDASI-BMT). The symptoms rated are feeling physically sick, weak, diarrhea, mouth sores, and bleeding. All symptoms are rated with reference to "the last 24 hours" on 0-10 numeric scales from "not present" to "as bad as you can imagine." MDASIBMT Total Symptom Severity score will serve as the symptom burden primary endpoint. The MDASI assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 numerical scale with 0 being "not present" and 10 being "as bad as you can imagine. Total symptom severity was calculated by averaging all 18 items in the scale |
At Day 7
|
|
Symptom Burden
Prazo: At Day 90
|
measured by M. D. Anderson Symptom Inventory Blood and Marrow Transplantaion (MDASI-BMT). The symptoms rated are feeling physically sick, weak, diarrhea, mouth sores, and bleeding. All symptoms are rated with reference to "the last 24 hours" on 0-10 numeric scales from "not present" to "as bad as you can imagine." MDASIBMT Total Symptom Severity score will serve as the symptom burden primary endpoint. The MDASI assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 numerical scale with 0 being "not present" and 10 being "as bad as you can imagine. Total symptom severity was calculated by averaging all 18 items in the scale |
At Day 90
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jun Mao, MD, MSCE, Memorial Sloan Kettering Cancer Center
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Manifestações Neurológicas
- Doenças do Sistema Nervoso
- Doenças Vasculares
- Doenças cardiovasculares
- Neoplasias
- Doenças do sistema imunológico
- Neoplasias por Tipo Histológico
- Manifestações Neurocomportamentais
- Doenças Hematológicas
- Doenças Linfáticas
- Distúrbios Linfoproliferativos
- Distúrbios imunoproliferativos
- Linfoma
- Neoplasias de Células Plasmáticas
- Distúrbios hemostáticos
- Paraproteinemias
- Distúrbios das Proteínas Sanguíneas
- Distúrbios hemorrágicos
- Distúrbios Perceptivos
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Doenças hemic e linfáticas
- Mieloma múltiplo
- Linfoma Não-Hodgkin
- Doença de Hodgkin
- Agnosia
- Efeitos fisiológicos das drogas
- Agentes do Sistema Nervoso Periférico
- Depressores do Sistema Nervoso Central
- Agentes do Sistema Sensorial
- Analgésicos
- Narcóticos
- Terapêutica
- Ações farmacológicas
- Ações e usos químicos
- Usos terapêuticos
- Terapias complementares
- Agentes do sistema nervoso central
- Analgésicos, Opioides
- Terapia de acupuntura
Outros números de identificação do estudo
- 20-264
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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