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- Ensayo clínico NCT03038516
'Palliative-D' Vitamin D to Palliative Cancer Patients (Palliative-D)
'Palliative-D' Vitamin D Supplementation to Palliative Cancer Patients - A Double Blind, Randomised Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
PROTOCOL IDENTITY AND OBJECTIVES: EudraCT Number 2017-000268-14 Protocol Title: Vitamin D supplementation to palliative cancer patients - A double blind, randomised controlled trial. Acronym: "Palliative-D" Trial Objectives: To test the hypothesis that vitamin D treatment during 12 weeks to palliative cancer patients can decrease opioid consumption, fatigue and infectious burden and increase quality of life.
INVESTIGATIONAL MEDICINAL PRODUCTS (IMP): Test ProductDetremin, MA holder Renapharma; Pharmaceutical Form: Oil Route of Administration: Oral route
METHODOLOGY Trial Design: Double-blind, parallel randomised and placebo controlled trial Dose/Duration 4000 IU/day for 12 weeks
Primary Endpoint:
The decline of opioid-consumption during 12 weeks in the vitamin D group compared to the placebo group, based on 3 measurements with 4 weeks intervals.
Secondary end Points:
- Decline in antibiotic consumption
- Improvement in quality of life
- Improvement in fatigue
- Vitamin D levels in serum after 12 weeks
- Association between opioid dose and genetic polymorphism in genes involved in the effect and metabolism of vitamin D in the body.
Efficacy Parameters:
Opioid dose, translated to fentanyl per hour measured at baseline and at week 4,8 and 12.
Antibiotic consumption expressed as % of days with antibiotics during the last 4 weeks measured at baseline and at week 4, 8 and 12.
Quality of Life measured with EORTC-QLQ-C15-PAL at baseline and after 12 weeks. Fatigue measured with EORTC-QLQ-C15-PAL at baseline and after 12 weeks. 25-hydroxyvitamin D levels in blood at baseline and after 12 weeks. ESAS (Edmonton Symptom Assessment Scale ) measured at baseline and at week 4, 8 and 12.
Safety Parameters: S-calcium will be controlled in all subjects at baseline, at week 4, 8 and 12 and U-calcium in selected cases Power: The least clinically meaningful effect is estimated to be a 20% decline in opioid dose compared to the placebo. To obtain this result with 80% power the number of patients is estimated to be 127 in each arm i.e. 254 patients in total. This includes a drop-out of 25% per group.
Statistical Analyse plan: The primary endpoint will be analysed using linear regression, using bias corrected and accelerated bootstrap confidence intervals, while controlling for baseline measure of opioid dose (similar to ANCOVA). Adjustment for other background variables - such as vitamin D-level at baseline, gender and age - will be made in a secondary analysis to gain efficiency. The continuous secondary endpoints will be analysed using the same method as the primary endpoint .
POPULATION OF TRIAL SUBJECTS Number of Subjects: 254 (127 vitamin D and 127 placebo) Description of Trial Subjects: Palliative Cancer Patients (any cancer form) with a life expectancy of more than 3 months.
TRIAL TIMETABLE First Subject In Aug 2017 Last Subject In Sept 2019 (25 months to include participants) Last Subject Out Dec 2019 End of intervention Dec 2019 End of follow up Dec2019 End of Trial: Dec 2020
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Stockholm, Suecia, 11219
- Stockholms Sjukhem ASIH
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Älvsjö, Suecia, 12559
- ASIH Stockholm Södra
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Stockholm
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Solna, Stockholm, Suecia, 171 54
- ASIH Stockholm Norr
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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:
- Patients admitted to ASIH Stockholm Södra or Stockholms Sjukhem.
- Incurable cancer patients with any type of cancer. They could have ongoing oncological treatment but only with palliative intention. No patients with ongoing oncological treatment with curative intended treated will be included.
- The life expectancy should be at least 3 months according to the clinical assessment of the study physician at the screening visit.
- The patient should have no cognitive failure, being able to comprehend oral and written information about the study.
- 25 OHD < 50 nmol/L.
- Men and women aged ≥18
- Signed 'informed consent'
Exclusion Criteria:
- Ongoing vitamin D supplementation at the time for inclusion.
- Serum level of 25-OH vitamin D3 >50 nmol/L
- Known sarkoidosis
- Treatment with tiazides or digoxin or digitoxin
- Primary hyperparathyroidism
- Hypercalcaemia (verified by a laboratory result younger than 2 month)
- Plans to leave the Stockholm county within 12 weeks of inclusion
- History of kidney stones
- Taking part of another clinical study involving drugs
- Hypersensitivity to cholecalciferol and/or any of the excipients
- Other criteria that could jeopardize the study or its intention as judged by the investigator
- Not being able to perform EORTC-QLQ-C15-PAL or ESAS
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Vitamin D
Cholecalciferol (Detremin) solved in MIGLYOL® 812
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To test the hypothesis that vitamin D treatment during 12 weeks to palliative cancer patients is superior to placebo in decreasing opioid consumption, fatigue and infectious burden and increase quality of life.
Otros nombres:
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Comparador de placebos: Placebo
MIGLYOL® 812
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To test the hypothesis that placebo is inferior to vitamin D treatment during 12 weeks to palliative cancer patients in decreasing opioid consumption,
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in opioid dose during 12 weeks
Periodo de tiempo: 12 weeks
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The change in decline of opioid-consumption during 12 weeks in the vitamin D group compared to the placebo group, based on 4 measurements with 4 weeks intervals.
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12 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in Antibiotic Consumption during 12 weeks
Periodo de tiempo: 12weeks
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Change in Antibiotic consumption expressed as % of days with antibiotics during the last 4 weeks measured at baseline and at week 4, 8 and 12.
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12weeks
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Change in Quality of life after 12 weeks
Periodo de tiempo: 12 weeks
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Change in Quality of Life measured with EORTC-QLQ-C15-PAL at baseline and after 12 weeks.
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12 weeks
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Change in Fatigue after12 weeks
Periodo de tiempo: 12 weeks
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Change in Fatigue measured with EORTC-QLQ-C15-PAL at baseline and after 12 weeks.
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12 weeks
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Change in 25-hydroxyvitamin D levels after 12 weeks
Periodo de tiempo: 12 weeks
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Change in 25-hydroxyvitamin D levels in blood at baseline and after 12 weeks.
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12 weeks
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Change in Symptom burden during 12 weeks
Periodo de tiempo: 12 weeks
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Change in Symptom burden measured with ESAS (Edmonton Symptom Assessment Scale) at baseline and at week 4, 8 and 12.
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12 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Linda Björkhem-Bergman, Assoc Prof, Stockholm Läns Landsting
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (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
- Palliative-D
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
producto fabricado y exportado desde los EE. UU.
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