Clinical course after substitution of Vitamin-D deficiency in patients with lung cancer or oesophageal carcinoma. Double blind randomised prospective, placebo-controlled study. - Vitamin D3 in thoracic surgery
- Conditions
- Patients admitted for treatment on a general thoracic surgery division with the following conditions:Lung cancerEsophageal cancerCancer of the gastroesophageal junction (GEJ)
- Registration Number
- EUCTR2009-017137-22-AT
- Lead Sponsor
- Klinische Abteilung für Thorax -u. Hyperbare Chirurgie, Medizinische Universität Graz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br><br>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 Outcome Measures
Name Time Method Secondary end point(s): Perioperative / Periinterventional course (duration of stay on ICU, total duration of stay, complications, in-hospital mortality)<br><br>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 <br>