None listed
Conditions
Brief summary
Low levels of vitamin D have been linked to an increased risk of developing colorectal cancer, higher rates of cancer recurrence following surgery and reduced patient survival. Previous studies have found that low Vitamin D levels are present in 50% of New Zealanders and 85% of bowel cancer patients at the time of diagnosis. This study is a randomised double blind, placebo controlled trial in colorectal cancer patients. Fifty patients will be randomised to receive a single dose of 100,000IU (2.5mg) of vitamin D or an identical placebo between 7 and 21 days prior to elective surgery. Following surgery tumour and normal colon samples from the resected bowel will be collected to analyse the biological effects of vitamin D in these tissues. If short duration preoperative exposure to vitamin D is to have an effect on colorectal cancer patients then vitamin D activity should be detectable in the tumour and colon tissue. The activation of Vitamin D pathways in tumour cells will be determined by identification of RNA generated from transcription of Vitamin D responsive genes. Macropahges will be isolated from the blood and tumour tissue of CRC patients will be infected bacteria in the laboratory. Their ability to prime the immune system and destroy pathogens will be measured. Results will be compared between treatment and placebo groups. Post-operative recovery will be recorded through ongoing review of patient notes, including infections and other complications graded by system and severity. Post-operative length of stay and details of post-operative adjuvant chemotherapy will be recorded. Clinico-pathological disease stage (TNM) will be captured through review of histology reports. Long term follow up over a minimum 5 year period for recurrence and survival will occur, but this data will not be included in the primary analysis. The study will provide new insight into how vitamin D supplementation affects tumour biology and inform future clinical studies aimed at improving patient outcome.
Interventions
Colorectal cancer patients scheduled to undergo routine elective surgery at Dunedin Hospital will be randomised to receive either a single oral 5mg dose of vitamin D3 (cholecalciferol), or identical placebo to be taken 7-21 days prior to surgery.
A dose of 5mg of vitamin D3 will consistently achieve therapeutic serum levels >80nmol/L, peaking at 1 week and gradually falling thereafter. The dose is safe and designed to rapidly achieve desirable levels without delaying surgery.
All patients en
Colorectal cancer patients scheduled to undergo routine elective surgery at Dunedin Hospital will be randomised to receive either a single oral 5mg dose of vitamin D3 (cholecalciferol), or identical placebo to be taken 7-21 days prior to surgery. A dose of 5mg of vitamin D3 will consistently achieve therapeutic serum levels >80nmol/L, peaking at 1 week and gradually falling thereafter. The dose is safe and designed to rapidly achieve desirable levels without delaying surgery. All patients enrolled will recieve all other treatment and care as they would have otherwise done so.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with colon cancer as diagnosed by colonoscopy, CT or Barium enema scheduled for elective surgery at Dunedin Hospital. Participant is willing and able to give informed consent for participation in the study. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Exclusion criteria
Hypercalcaemia (> 2.6mmol/L). Hypervitaminosis D. Renal osteodystrophy with hyperphosphatemia. Renal failure (requiring renal replacement therapy). Sarcoidosis and possibly other granulomatous diseases. Patients receiving treatment with thiazide diuretics. Advanced liver disease (Childs-Pugh B or C). Patients in whom there would be less than 7 days between randomisation and surgery. Female participants who are pregnant, lactating or planning pregnancy during the course of the study. Patients with rectal cancer due to difficulties obtaining fresh tissue without compromising histopathological examination.
Outcome results
None listed