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Clinical Trials/ACTRN12615001277538
ACTRN12615001277538
Completed
Not Applicable

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

Prof Margreet Vissers0 sites12 target enrollmentNovember 24, 2015
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ConditionsColorectal cancerCancer - Bowel - Back passage (rectum) or large bowel (colon)

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal cancer
Sponsor
Prof Margreet Vissers
Enrollment
12
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 24, 2015
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Prof Margreet Vissers

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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