Manejo del dolor y la carga de síntomas causados por la quimioterapia en personas con mieloma o linfoma
Tratamiento del dolor con ahorro de opioides en pacientes con mieloma y linfoma sometidos a dosis altas de quimioterapia (OPTIMAL-HiChemo): ensayo controlado aleatorizado
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10065
- Memorial Sloan Kettering Cancer Center
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Washington
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Seattle, Washington, Estados Unidos, 98109
- Seattle Cancel Care Alliance (Data Collection Only)
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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 activo: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
the Number of Patients Using Opioids at a Given Time
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Neoplasias
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Manifestaciones neuroconductuales
- Enfermedades hematológicas
- Enfermedades linfáticas
- Trastornos linfoproliferativos
- Trastornos inmunoproliferativos
- Linfoma
- Neoplasias De Células Plasmáticas
- Trastornos hemostáticos
- Paraproteinemias
- Trastornos de proteínas en sangre
- Trastornos hemorrágicos
- Trastornos de la percepción
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Enfermedades hemic y linfáticas
- Mieloma múltiple
- Linfoma No Hodgkin
- Enfermedad de Hodgkin
- Agnosia
- Efectos fisiológicos de las drogas
- Agentes del sistema nervioso periférico
- Depresores del sistema nervioso central
- Agentes del sistema sensorial
- Analgésicos
- Narcóticos
- Terapéutica
- Acciones farmacológicas
- Acciones y usos químicos
- Usos terapéuticos
- Terapias complementarias
- Agentes del sistema nervioso central
- Analgésicos, Opioides
- Terapia de acupuntura
Otros números de identificación del estudio
- 20-264
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
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