Vitamin C for Colorectal Cancer: A clinical window study to assess high dose vitamin C administration in colorectal cancer patients
- Conditions
- Colorectal cancerCancer - Bowel - Back passage (rectum) or large bowel (colon)
- Registration Number
- ACTRN12615001277538
- Lead Sponsor
- Prof Margreet Vissers
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 12
1.Confirmed colorectal cancer (via biopsy histology) and scheduled to undergo surgery
2.Good physical functional status – ECOG grade 0 or 1
3.Aged >/= 18 years
4.Able to give informed consent to participate in the study
5.Signed informed consent to donate tissue (biopsy tissue and surplus tissue from surgery) and blood samples
6.Adequate bone marrow, hepatic, renal and cardiac function
7.Able to come to the clinical research unit four times in the week prior to surgery for IV infusions
1.Receiving neoadjuvant therapy
2.Supplementing with vitamin C >/= 1g/d
3.Serum creatinine concentration >175 µmol/L
4.Erythrocyte glucose-6-phosphate dehydrogenase activity deficiency
5.Serious gastrointestinal disorders including active bleeding
6.Patients with serious or uncontrolled infection, cardiac or neurological conditions
7.Dementia or altered mental status that would render informed consent impossible
8.Pregnant or lactating women
9.Any abnormal laboratory value or medical condition that would, in the investigators’ judgement, make the patient a poor candidate for the study
10.Current calcium oxalate nephropathies with the potential to block urinary flow
11.Adverse response to test dose of 25 g IV vitamin C given on the first intervention day
12.Individuals with diabetes as HDVC can have a hypoglycaemic effect and can also interfere with some glucose finger stick devices
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ascorbate uptake - plasma, normal colon tissue, tumour tissue (measured by HPLC with electrochemical detection) - composite primary outcome[Treatment group: at diagnostic colonoscopy (blood and tissue), prior to each of four daily vitamin C infusions (blood), following surgical resection of tumour (tissue)<br><br>Control group: at diagnostic colonoscopy (blood and tissue), prior to surgery (blood), following surgical resection of tumour (tissue)<br>];Changes in tumour biology - HIF-1 protein levels/activity i.e. downstream gene expression e.g. VEGF, GLUT-1, BNIP3, CAIX (measured by Western blotting and ELISA)[Tissue taken at diagnostic colonoscopy and tumour resection];Changes in tumour histopathology e.g. vitamin C transporter status, immune infiltrate, micro-vessel density (measured by immunohistochemistry)[Tissue taken at diagnostic colonoscopy and tumour resection]
- Secondary Outcome Measures
Name Time Method Changes in markers of inflammation e.g. plasma CRP, TNF, IL-6 (measured by immunoassay and ELISA)[Blood taken at diagnostic colonoscopy and day prior to surgery];Changes in chromosome modifications (measured by ELISA)[Tissue taken at diagnostic colonoscopy and tumour resection];Patient quality of life (measured by questionnaires e.g. EORTC-QLQ, MFSI, VAS)[At diagnostic colonoscopy, day before surgery, and at six weeks, three months, six months post surgery];Wound healing i.e. whether wound healed with or without infection, as diagnosed by treating physician[At six weeks, three months, six months post surgery];Feasibility of study e.g. patient accrual rate and patient acceptance of schedule (Likert scale survey)[At six weeks post surgery]