Vitamin C for Colorectal Cancer: A clinical window study to assess high dose vitamin C administration in colorectal cancer patients

A clinical window study in colorectal cancer patients to assess the effects of high dose vitamin C administration on tumour biology

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615001277538

Enrollment

Registered

2015-11-24

Start date

2016-03-23

Completion date

2016-12-12

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is to carry out a clinical window study in patients with colorectal cancer to determine whether vitamin C administered intravenously (high dose vitamin C) can reach tumours and produce measureable changes in tumour biology.

Interventions

Participants will receive a high dose vitamin C infusion (1g vitamin C/kg body weight) each day for four days prior to surgical resection of tumour. All infusions will be administered by research nurse.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Outcome results