Colorectal adenocarcinoma Cancer Malignant neoplasm of colon
Conditions
Interventions
Subjects will be randomised to receive 200 mg artesunate or placebo orally once daily for 14 days whilst awaiting surgery for colorectal adenocarcinoma with curative intent.
Sponsors
St George's, University of London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 21 - 80 years, male or female 2. With biopsy confirmed single primary site colorectal adenocarcinoma 3. With stages I - IIIb (defined according to conventional criteria) 4. With planned curative resection 5. With written, informed consent
Exclusion criteria
Exclusion criteria: 1. Contraindication to use of artesunate due to hypersensitivity 2. Pregnancy (of any stage) 3. History of hearing or balance problems 4. Immunosuppression or concomitant medication known to interact with artesunate 5. Weight less than 50 kg or greater than 100 kg 6. Severe anaemia (haemoglobin less than 8 g/dl) 7. Other planned intervention, apart from standard of care 8. Inability to give informed consent 9. Inability or unwillingness to take effective contraception in women of child-bearing age 10. Chronic kidney disease of NKF D/QOFI stage 3 or above (estimated glomerular filtration rate [eGFR] less than 60 ml/min) 11. Bilirubin greater than 2 x upper limit of normal in the absence of haemolysis, or known chronic liver disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A significant difference in the proportion of cells that exhibit apoptosis between the two treatment groups (placebo and artesunate), assessed at the time of surgery, after two weeks of drug treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Tolerability of artesunate compared with placebo. Tolerability will be assessed according to conventional criteria used in clinical trials, and scored on standardised pro-formas. 2. Comparisons will also be made between baseline haematological and biochemical variables (full blood count, liver function tests, urea and electrolytes), and these measures repeated once treatment stops and before surgery Assessed after one week and at the end of drug treatment. | — |
Countries
United Kingdom
Outcome results
None listed