- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02560740
A Study of the Efficacy and Safety of PerOx Quench on the Prevention of Oxaliplatin Treatment Induced Neuropathy
A Randomised, Double-blinded, Placebo Controlled Study to Assess the Efficacy and Safety of PerOx Quench or Placebo for 35 Days on the Prevention of Oxaliplatin Treatment Induced Sensory Neuropathy
Chemotherapy-induced peripheral neuropathy (CIPN) is a progressive, enduring, and often irreversible condition featuring pain, numbness, tingling and sensitivity to cold in the hands and feet (sometimes progressing to the arms and legs) that afflicts between 30 and 40 percent of patients undergoing chemotherapy.
American Society of Clinical Oncology (ASCO) guidance on The Journal of Clinical Oncology (JCO, 2014 April 14) does not recommend any prophylaxis regimen for CIPN.
PerOx Quench has unique membrane protection and anti-oxidative function as a special food, that's why to try to explore its preventive effects on CIPN prevention induced by Oxaliplatin for colorectal cancer or gastric cancer chemotherapy.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Shanghai
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Shanghai, Shanghai, Porcelana, 200003
- Shanghai Changzheng Hospital
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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 between 18-80 years old, male and female
- Without anti-cancer treatment before randomization, ECOG score 0-2
- Estimate to bear at least 4 cycles chemotherapy treatment with normal function of heart, lungs, liver and kidneys.
- Survival expectation ≥6 months
- Signed Informed Consent Form, willing to follow all study procedures
Exclusion Criteria:
- Received chemotherapy treatment within 4 weeks before randomization.
- Current peripheral neuropathy(by chemotherapy, diabetes mellitus, alcoholic disease) and relative symptoms with relevant treatment.
- Concurrent treatment within 30 days after randomization with the following drugs: Calcium-Magnesium injection, glutathione, and similar ingredients with PerOx Quench (such as polyene phosphatidyl choline).
Laboratory tests found not suitable for chemotherapy patients (Absolute neutrophil count <2.0×10*9/L<2,000/mm3>; or platelet count<100× 10*9/L<100,000/mm3>; or hemoglobin <10/dl; or serum total bilirubin >2 Upper Limit Of Normal (ULN), alanine aminotransferase (ALT)/aspartate aminotransferase (AST)>3 Upper Limit Of Normal (ULN); or serum creatinine >1.5 Upper Limit Of Normal (ULN) <or creatinine clearance rate
≤60ml/min>).
- Pregnancy, lactation and reluctant to using contraception women.
- Patients with symptomatic brain metastases and other mental disorders could not be self assessment.
- Alcohol and/or drug abuse or doctors determine compliance's claim.
- Within a month in other clinical trial subjects.
- Once into the group of this study, or random within eight weeks before using this product.
- personnel involved this study.
- Not completed independent self assessment of patients.
- Other researchers determine does not fit to participate in this study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: PerOx Arm
PerOx Quench arm 4g/sachet each time by water, q6h
|
By 1 week pretreatment of PerOx Quench and following 4 weeks taken to decrease the CIPN incidence.
|
Comparador de placebos: Comparative Arm
PerOx Quench placebo 4g/sachet each time by water, q6h
|
By 1 week pretreatment of Placebo and following 4 weeks taken to record the CIPN incidence.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Evaluation of Oxaliplatin-induced Peripheral Neuropathy incidence rate on the 35 day in 2 arms.
Periodo de tiempo: 35 day after randomization
|
Peripheral neuropathy incidence rate was measured by frequency and percentage of any Oxaliplatin-induced Peripheral Neuropathy symptoms.
|
35 day after randomization
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Evaluation of Oxaliplatin-induced Peripheral Neuropathy severity by PI on the 35 day in 2 arms.
Periodo de tiempo: 35 day after randomization
|
Peripheral neuropathy severity by PI was measured by each related symptom grading, and the most serious symptom will be evaluated by National Cancer Institute Common Toxicity Criteria (NCI-CTC) classification.
|
35 day after randomization
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Evaluation of Oxaliplatin-induced Peripheral Neuropathy severity by subjects on the 35 day in 2 arms.
Periodo de tiempo: 35 day after randomization
|
Peripheral neuropathy severity by subjects was measured by Visual Analogue Scale (VAS) score (Scores range from 0 [no symptom] to 10 [worst possible symptom]).
|
35 day after randomization
|
Evaluation of subjects quality of life difference in 2 arms on the 35 day.
Periodo de tiempo: 35 day after randomization
|
Quality of Life (QoL) will be measured by European Organization for Research and Treatment of Cancer quality of life questionaire C30 (EORTCQLQ-C30) questionnaire.
|
35 day after randomization
|
Evaluation of subjects Eastern Cooperation Oncology Group-Performance Score (ECOG-PS) difference in 2 arms on the 35 day.
Periodo de tiempo: 35 day after randomization
|
Eastern Cooperation Oncology Group-Performance Score (ECOG-PS) will be measured by ECOG-PS score.
|
35 day after randomization
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Evaluation of the Adverse Events (AEs) incidence rate on 35 day in 2 arms.
Periodo de tiempo: Sign ICF to 35 day after randomization
|
The Adverse Events (AEs) incidence rate was measured by frequency and percentage of participants with Treatment-Related Grade 3 or above Adverse Events during this trial.
The grade of Adverse Events was assessed by Common Toxicity Criteria Adverse Event (CTCAE) v4.0.
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Sign ICF to 35 day after randomization
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Jiejun WANG, MD., Ph.D, Shanghai Changzheng Hospital
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
- POQ 00001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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. .
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