Criocompresión para reducir la neuropatía periférica inducida por la quimioterapia en el cáncer ginecológico - COHORTE 2
Uso de criocompresión para reducir la neuropatía periférica inducida por quimioterapia en el cáncer ginecológico: un ensayo controlado aleatorio - COHORTE 2
The investigators aim to determine the effect of cryotherapy wraps plus compression therapy (henceforth referred to as cryocompression) versus cryotherapy wraps alone on the incidence and degree of chemotherapy-induced peripheral neuropathy in patients with gynecologic cancer using a noninferiority design. The investigators also aim to determine the effect of cryocompression versus cryotherapy on patient tolerability and patient and staff satisfaction.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Participants will be randomized by patient to receive cryotherapy wraps plus compression therapy (cryocompression) versus cryotherapy wraps alone applied to the bilateral hands and feet. Participants will receive cryotherapy (+/- compression) for the duration of their taxane infusions. Participants will be asked to complete the FACT-NTX survey and a PNQ neuropathy surveys at each infusion visit to evaluate symptoms related to neuropathy. Participants will also complete a brief acceptability and tolerability survey at each visit. Lastly, a staff satisfaction survey will be administered at each visit as well. The investigators will test the hypothesis that the average final visit FACT-NTX11 scores in the cryotherapy group are noninferior to the cryocompression group with a noninferiority margin of 2.5 points. The investigators will routinely monitor for the following adverse events: frost bite, (unexpected) hospitalizations, and death.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Amelia Scott
- Número de teléfono: 919-613-4584
- Correo electrónico: amelia.lorenzo@duke.edu
Ubicaciones de estudio
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Connecticut
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Hartford, Connecticut, Estados Unidos, 06106
- Reclutamiento
- Hartford Healthcare Cancer Institute
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Investigador principal:
- Amy Brown, MD
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Contacto:
- Siobhan Reilly
- Número de teléfono: 860-696-4958
- Correo electrónico: Siobhan.Reilly@hhchealth.org
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Middletown, Connecticut, Estados Unidos, 06457
- Reclutamiento
- Middlesex Health Cancer Center - Middletown
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Investigador principal:
- Karthikeyan Kandevelou, MD
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Contacto:
- Loriann MacLean, MSN
- Número de teléfono: (860)358-2015
- Correo electrónico: loriann.maclean@midhosp.org
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- Reclutamiento
- Duke University Medical Center
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Investigador principal:
- Laura Havrilesky, MD
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Contacto:
- Amelia Scott
- Número de teléfono: (919) 613-4584
- Correo electrónico: amelia.lorenzo@duke.edu
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Virginia
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Roanoke, Virginia, Estados Unidos, 24016
- Reclutamiento
- Carilion Clinic
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Investigador principal:
- Erin Saks, MD
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Contacto:
- Anna Derrick
- Número de teléfono: 540-581-0160
- Correo electrónico: acderrick@carilionclinic.org
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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:
- Gynecologic cancer diagnosis (ovarian, cervical, endometrial cancer; adenocarcinomas of likely primary gynecologic origin based on cytology or FNA in conjunction with radiologic impression will be eligible)
- Plan to receive at least 6 cycles of paclitaxel administered every 3 weeks at the Duke Cancer Center or Macon Pond or at the Carilion Clinic in Roanoke, VA. Patients receiving neoadjuvant chemotherapy with a plan for interval debulking will be eligible.
- ECOG (Eastern Cooperative Oncology Group) performance status of 0-1
Exclusion Criteria:
- Treated with prior neurotoxic chemotherapeutic agents
- Baseline diagnosis of peripheral neuropathy such as diabetic neuropathy, or conditions including but not limited to fibromyalgia, cryoglobulinemia and Raynaud's disease.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Crioterapia
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Participants will receive cryotherapy on both hands and feet |
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Experimental: Compresión con crioterapia
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Participants will receive cryotherapy on both hands and feet Participants will receive compression on both hands and feet |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Functional Assessment of Cancer Therapy (FACT) -Taxane [FACT-NTX] (patient reported assessment) over time
Periodo de tiempo: Up to two months after completion of chemotherapy, an average of 6 months
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The FACT-NTX is a patient self-reported 11-item questionnaire used for evaluating symptoms and concerns specifically associated with chemotherapy induced neuropathy. The total score ranges from 0-44, and a lower FACT-NTX score corresponds to worsening neuropathy. For both the FACT-NTX and the sensory subscale of the FACT-NTX, a significant decrease in the score is defined as a decrease exceeding 10% from baseline. |
Up to two months after completion of chemotherapy, an average of 6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Tolerability of cryocompression: scale
Periodo de tiempo: Up to two months after completion of chemotherapy, an average of 6 months
|
Subjects will be asked to complete a cryocompression tolerability assessment after each chemotherapy session in which they will answer the question, "How tolerable was the cryocompression procedure for you?" on a scale from 0 to 100. A score of 0 means "not tolerable at all" and a score of 100 is "very tolerable". Pain, abnormal sensation, and adherence to cryocompression will also be evaluated as patient-reported measures of tolerability. |
Up to two months after completion of chemotherapy, an average of 6 months
|
|
Acceptability: scale
Periodo de tiempo: Up to two months after completion of chemotherapy, an average of 6 months
|
Subjects will be asked to complete a cryocompression acceptability assessment after each chemotherapy session in which they answer the questions, "How acceptable was the cryocompression procedure to you?" and "How likely are you to continue with cryocompression at your next chemotherapy treatment?" on a scale from 0 to 100, with 0 being "not acceptable, not likely to continue" and 100 being "very acceptable, very likely to continue". |
Up to two months after completion of chemotherapy, an average of 6 months
|
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Measure of manageability and acceptability for staff involved in the participants' care
Periodo de tiempo: Up to two months after completion of chemotherapy, an average of 6 months
|
Staff will be asked to complete an acceptability assessment after each chemotherapy session in which they will answer the question, "How manageable or acceptable was this patient's cryotherapy/cryocompression therapy to you in working with a patient receiving chemotherapy?" on a scale from 0 to 100. A score of 0 means "not at all acceptable" and a score of 100 is "complete acceptable". They will also be asked "In your experience, compare the ease of use of the cryotherapy wrap versus plastic ice bags" on a scale from 0 to 100. A score of 0 means "cryotherapy wraps are much harder," and a score of 100 means "cryotherapy wraps are much easier." |
Up to two months after completion of chemotherapy, an average of 6 months
|
|
Change in Patient Neurotoxicity Questionnaire [PNQ] (patient reported assessment) over time
Periodo de tiempo: Up to two months after completion of chemotherapy, an average of 6 months
|
PNQ is a patient-reported questionnaire that consists of 2 items, representing motor and sensory components, with increasing grades for worsening symptoms. Patients will respond to each question for each of their 4 extremities by grading sensory and motor symptoms as A (no neuropathy), B (mild neuropathy), C (moderate neuropathy that does not interfere with activities of daily living [ADL]), D (moderate neuropathy that does interfere with ADL), or E (severe neuropathy that interferes with ADL). |
Up to two months after completion of chemotherapy, an average of 6 months
|
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Chemotherapy Dose
Periodo de tiempo: Up to two months after completion of chemotherapy, an average of 6 months
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Study staff will record the taxol dose at each cycle |
Up to two months after completion of chemotherapy, an average of 6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Laura Havrilesky, DUHS
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Pro00106236_1
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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