Evaluation of Cytotoxicity and Genetic Changes of High Dose Vitamin C Infusions in Castration Resistant Metastatic Human Prostate Cancer
Vitamin C for palliative treatment:
Intravenous vitamin C has been used since the 1970's for terminally ill cancer patients
claiming big increases in survival time. The efficacy of the drug is questioned and no
randomized, controlled trial of Vitamin C's efficacy on cancer patients survival has been
made.
Recent results from in vitro and xenograft studies in mice has shown some promise for
vitamin c as a cytotoxic agent against cancer cells.
The following parameters are recorded for baseline:
- Biomarkers (PSA, bALP, NTX, PINP)
- Routine blood work (hgb, creatinine, p-vitamin c etc.)
- Radio nucleotide bone scintigraphy
- Prostate biopsies for later microarray (Affymetrix ST1.0)
- Urine samples 8-oxo-guanine(for oxidative DNA-damage measurements)
These parameters are repeated after treatment, usually after 12 to 26 weeks after the first
vitamin c infusion.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
PSA changes after 12-20 weeks of treatment
12, 20 and 26 weeks
No
Kari J Mikines, MD, DsMC
Principal Investigator
Copenhagen University Hospital at Herlev
Denmark: The Regional Committee on Biomedical Research Ethics
2008-008692-33
NCT01080352
November 2010
March 2013
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