The effect on quality of life of Vitamin D administration for advanced cancer treatment.
- Conditions
- The effect on quality of life of Vitamin D administration for advanced cancer treatment. A randomized controlled trialTherapeutic area: Health Care [N] - Health Care Quality, Access, and Evaluation [N05]
- Registration Number
- EUCTR2013-003478-29-ES
- Lead Sponsor
- Maria Nabal Vicuña (Paliative Care Supportive Team-Hospital Universitari Arnau de Vilanova de Lleida)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Patients satisfying inclusion criteria will be randomly assigned to receive vitamin D or placebo. Eligible patients
will be adults (18 years or older) having a locally advanced or metastatic or inoperable solid cancer under palliative care,
upon signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 274
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria will be having a Karnofsky < 30%, being pregnant or breast-feeding
females, undergoing severe liver or renal (GRF<60) failure, having a cognitive deterioration (more than 5 mistakes in
Pfeiffer test)., suffering from significant (more than 6 out of 10 in a Numerical Rating Scale 0:10) pain, dyspnea, nausea or
vomits, or having received chemo or radiation therapy within the last 3 weeks prior to inclusion, or with the possibility of
iniciating a new cycle of chemo or radiation therapy within a period of 6 weeks after their inclusion date.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method