Patients admitted for treatment on a general thoracic surgery division with the following conditions: Lung cancer Esophageal cancer Cancer of the gastroesophageal junction (GEJ)
Conditions
Interventions
Trade Name: Oleovit D3 Tropfen
Product Name: Oleovit D3 Tropfen
Pharmaceutical Form: Oral drops
INN or Proposed INN: Colecalciferol
Other descriptive name: COLECALCIFEROL CONCENTRATE (OILY FORM)
Conc
Sponsors
Klinische Abteilung für Thorax -u. Hyperbare Chirurgie, Medizinische Universität Graz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically proven lung cancer Histologically proven esophageal cancer Histologically proven cancer of the gastroesophageal junction (GEJ) Age =18 years Possibility of oral or enteral administration of the study medication (oral intake, nasogastric tube, jejunal tube, gastrostomy tube) 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Moribund patient expected to die within 24 hours Hypercalcaemia (total calcium >2.65 mmol/l OR ionized calcium >1.35 mmol/l) Severely impaired gastrointestinal motility (ileus, residual gastric volume > 400 ml) Known granulomatous diseases (tuberculosis, sarcoidosis) Known history of recent kidney stones (=1 year) Women of childbearing age Pregnancy Withdrawal of patients IC Participation in other interventional studies Patients unable to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the 25(OH)Vitamin D -levels in the patient collective admitted for general thoracic surgery, and to initiate subsitution therapy in case of Vitamin D definicency.;Secondary Objective: To assess the further course of the abovementioned collective.;Primary end point(s): Determination of the 25(OH)Vitamin D - levels in a patient collective requiring general thoracic surgery. The main hypothesis of the study is, that high-dose supplementation of vitamin D will reduce perioperative/periinterventional morbidity and mortality and will prolong survival or tumour-free survival in patients treated for lung cancer or oesophageal carcinoma. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Perioperative / Periinterventional course (duration of stay on ICU, total duration of stay, complications, in-hospital mortality) Posttherapeutic course of lung cancer or oesophageal carcinoma (recurrence-free survival, interval to progression, overall survival) in the treatment group and in the control group | — |
Countries
Austria
Outcome results
None listed