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Trial registered on ANZCTR


Registration number
ACTRN12615001277538
Ethics application status
Approved
Date submitted
19/11/2015
Date registered
24/11/2015
Date last updated
16/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Vitamin C for Colorectal Cancer: A clinical window study to assess high dose vitamin C administration in colorectal cancer patients
Scientific title
A clinical window study in colorectal cancer patients to assess the effects of high dose vitamin C administration on tumour biology
Secondary ID [1] 287933 0
None
Universal Trial Number (UTN)
U1111-1173-0882
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer 296813 0
Condition category
Condition code
Cancer 297042 297042 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 293284 0
Treatment: Other
Comparator / control treatment
Control group will receive no high dose vitamin C intervention prior to surgery.
Control group
Active

Outcomes
Primary outcome [1] 296642 0
Ascorbate uptake - plasma, normal colon tissue, tumour tissue (measured by HPLC with electrochemical detection) - composite primary outcome
Timepoint [1] 296642 0
Treatment group: at diagnostic colonoscopy (blood and tissue), prior to each of four daily vitamin C infusions (blood), following surgical resection of tumour (tissue)

Control group: at diagnostic colonoscopy (blood and tissue), prior to surgery (blood), following surgical resection of tumour (tissue)
Primary outcome [2] 296643 0
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)
Timepoint [2] 296643 0
Tissue taken at diagnostic colonoscopy and tumour resection
Primary outcome [3] 296644 0
Changes in tumour histopathology e.g. vitamin C transporter status, immune infiltrate, micro-vessel density (measured by immunohistochemistry)
Timepoint [3] 296644 0
Tissue taken at diagnostic colonoscopy and tumour resection
Secondary outcome [1] 318978 0
Changes in markers of inflammation e.g. plasma CRP, TNF, IL-6 (measured by immunoassay and ELISA)
Timepoint [1] 318978 0
Blood taken at diagnostic colonoscopy and day prior to surgery
Secondary outcome [2] 318979 0
Changes in chromosome modifications (measured by ELISA)
Timepoint [2] 318979 0
Tissue taken at diagnostic colonoscopy and tumour resection
Secondary outcome [3] 318980 0
Patient quality of life (measured by questionnaires e.g. EORTC-QLQ, MFSI, VAS)
Timepoint [3] 318980 0
At diagnostic colonoscopy, day before surgery, and at six weeks, three months, six months post surgery
Secondary outcome [4] 318981 0
Wound healing i.e. whether wound healed with or without infection, as diagnosed by treating physician
Timepoint [4] 318981 0
At six weeks, three months, six months post surgery
Secondary outcome [5] 318982 0
Feasibility of study e.g. patient accrual rate and patient acceptance of schedule (Likert scale survey)
Timepoint [5] 318982 0
At six weeks post surgery

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7343 0
New Zealand
State/province [1] 7343 0
Canterbury

Funding & Sponsors
Funding source category [1] 292414 0
Government body
Name [1] 292414 0
Health Resarch Council of New Zealand
Address [1] 292414 0
Level 3
110 Stanley St
Grafton
Auckland 1010
Country [1] 292414 0
New Zealand
Primary sponsor type
Individual
Name
Prof Margreet Vissers
Address
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 291104 0
None
Name [1] 291104 0
Address [1] 291104 0
Country [1] 291104 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293879 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 293879 0
Ministry of Health
Freyberg Building
PO Box 5013
Wellington 6011
Ethics committee country [1] 293879 0
New Zealand
Date submitted for ethics approval [1] 293879 0
28/08/2015
Approval date [1] 293879 0
23/09/2015
Ethics approval number [1] 293879 0
15/STH/145

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61662 0
Prof Margreet Vissers
Address 61662 0
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 61662 0
New Zealand
Phone 61662 0
64 3 364 1524
Fax 61662 0
Email 61662 0
margreet.vissers@otago.ac.nz
Contact person for public queries
Name 61663 0
Prof Margreet Vissers
Address 61663 0
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 61663 0
New Zealand
Phone 61663 0
64 3 364 1524
Fax 61663 0
Email 61663 0
margreet.vissers@otago.ac.nz
Contact person for scientific queries
Name 61664 0
Prof Margreet Vissers
Address 61664 0
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 61664 0
New Zealand
Phone 61664 0
64 3 364 1524
Fax 61664 0
Email 61664 0
margreet.vissers@otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary