The effect on quality of life of Vitamin D administration for advanced cancer treatment. A randomized controlled trial
Conditions
Interventions
Trade Name: Vitamine D3 Kern Pharma
Product Name: VITAMINA D3 or COLECALCIFEROL
Pharmaceutical Form: Oral solution
INN or Proposed INN: Vitamina D3
Current Sponsor code: Hospital Universitari Arnau de
Sponsors
Maria Nabal Vicuña (Paliative Care Supportive Team-Hospital Universitari Arnau de Vilanova de Lleida)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy of a new therapeutic modality with vitamin D3 to enhance patient?s reported health-related quality of life of these patients.;Secondary Objective: 1) Evaluate the efficacy of a new therapeutic modality with vitamin D3 to enhance physical performance (Karnofsky and PPS scales). 2) Evaluate the efficacy of a new therapeutic modality with vitamin D3 to enhance perceived fatigue (FACT-F). 3) Evaluate the efficacy of the proposed therapeutic modality with vitamin D3 to achive serum levels of 25-hydroxy vitamin D above 30 ng/mL. 4) Evaluate the effect on tumor biomarkers. 5) Explore the relationship between vitamin D treatment compliance and serum levels of vitamin D. 5) Explore the relationship between serum levels of vitamin D and renal function. 6) Explore the dose-response relationship in the group of patients with vitamin D3 for the main outcome. 7) Assess the cost-utility of the proposed therapeutic modality with vitamin D3.;Primary end point(s): Quality of life questionnaires EORTC QLQ-C15-PAL;Timepoint(s) of evaluation of this end point: FACT-F questionnaires, serum 25-hydroxyvitamin, tumor biomarkers, cumpliemto treatment, relationship of vitamin D serum levels with renal function, EQ5D questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Day 0, day 14, day 28 and day 42;Timepoint(s) of evaluation of this end point: Day 0, day 14, day 28 and day 42 | — |
Countries
Spain
Contacts
Public ContactClinical Trials Office
Maria Nabal Vicuña (Paliative Care Supportive Team)
Outcome results
None listed