None listed
Conditions
Brief summary
This study is looking at how we can most effectively use Cimetidine, an ulcer-healing drug that has been available for over 30 years, to try to improve the outcome in patients having surgery to remove bowel cancer. This drug can support the immune system to remain fully active following the stress of surgery, and might reduce the risk of cancer cells spreading during and after the operation. However it is not clear how long patients may need to take the drug to gain the maximum benefit, and this study is aiming to clarify that by examining the impact of surgery on immune responses and what effect cimetidine has on them. We will randomise patients to take cimetidine or placebo tablets twice a day for 5 weeks, starting a week before the operation, and will look at immune responses in blood tests taken 6 times over those 5 weeks. We will also look at whether patients have any problems taking the tablets, especially immediately after the operation, how well they recover from surgery and whether they have recurrence of the bowel cancer over the next few years.
Interventions
Cimetidine oral tablets 800mg twice daily for 5 weeks starting a week before surgery
Sponsors
Waikato Hospital
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
1. Biopsy-proven colorectal adenocarcinoma planned for resection with curative intent. 2. Age at least 18 years 3. Accessible for treatment and follow up 4. Written informed consent
Exclusion criteria
1. Clinical T1 tumours such as a pedunculated polyp 2. Radiological or clinical evidence of unresectable primary tumours or metastatic disease beyond regional nodes 3. Unable to swallow or absorb study tablets 4. Currently taking H2-antagonists (cimetidine, ranitidine, famotidine, nizatidine) 5. Taking medications during the period of study treatment that have clinically significant interactions with cimetidine (including warfarin, phenytoin, theophylline and nifedipine) 6. Significantly impaired renal function (serum creatinine > 1.25 x upper limit of normal) 7. Significant liver impairment (bilirubin > 30 micromol/l; Alkaline phosphatase (ALP), aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 x upper limit of normal) 8. Other invasive malignancy within 5 years except adequately-treated basal cell or squamous cell carcinoma of skin or in-situ carcinoma of the cervix 9. Pregnant or breast feeding women 10. Major surgery within prior 30 days, excluding defunctioning colostomy or ileostomy
Outcome results
None listed