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Vitamin C as an Anti-cancer Drug

2014-08-27 03:15:29 | BioPortfolio

Summary

Can high dose, intravenous Vitamin C prolong life for patients with metastatic prostate cancer?

Prostate cancer is the most common cancer (excluding skin cancer) in men in Denmark and the Unites States. When metastatic disease is present cure is no longer possible. The main treatment at this stage is castration, either surgical or medical, ending the patients testosterone production and causing a temporary regression in disease activity.

Eventually, the cancer will progress, usually within 2 years from the castration, with a more aggressive course and a survival of 2-3 years.

The current treatment option for the patients, who have undergone castration and have disease progression, is chemotherapy with only limited gains in quality of life and survival.

This clinical study is a phase 2 study to evaluate the effects of high dose intravenous vitamin c in subjects with early castration resistant prostate cancer.

Primary endpoint:

- Prostate specific antigen (PSA) changes after 12 to 20 weekly vitamin c infusions

Secondary endpoints:

- Bone metastases changes after 12 to 20 weekly vitamin c infusions

- Changes in PCA-3, bone specific alkaline phosphates, oxidative DNA-damage, PNP, NTX after 12 to 20 weekly vitamin c infusions

- RNA-expression changes in prostatic tumor tissue after 12 to 20 weekly vitamin c infusions

- RNA-expression changes in lymphocytes after 12 to 20 weekly vitamin c infusions

Tertiary endpoints:

- Pharmacokinetics of vitamin c in the elderly cancer patients

Methods and material:

- 80 subjects are included

- Each subject receives a weekly infusion of 20 grams vitamin c (in the form of ascorbate) for 12 to 20 weeks

Description

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, PCA-3, 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.

Study Design

Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Prostatic Neoplasms

Intervention

Ascorbic Acid (Vitamin C)

Location

Departmen of Urology, Copenhagen University Hospital at Herlev
Herlev
DK
Denmark
2730

Status

Not yet recruiting

Source

Copenhagen University Hospital at Herlev

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:29-0400

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Medical and Biotech [MESH] Definitions

A six carbon compound related to glucose. It is found naturally in citrus fruits and many vegetables. Ascorbic acid is an essential nutrient in human diets, and necessary to maintain connective tissue and bone. Its biologically active form, vitamin C, functions as a reducing agent and coenzyme in several metabolic pathways. Vitamin C is considered an antioxidant.

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Membrane transport proteins that actively co-transport ASCORBIC ACID and sodium ions across the CELL MEMBRANE. Dietary absorption of VITAMIN C is highly dependent upon this class of transporters and a subset of SODIUM GLUCOSE TRANSPORTERS which transport the oxidized form of vitamin C, DEHYDROASCORBIC ACID.

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A lipid cofactor that is required for normal blood clotting. Several forms of vitamin K have been identified: VITAMIN K 1 (phytomenadione) derived from plants, VITAMIN K 2 (menaquinone) from bacteria, and synthetic naphthoquinone provitamins, VITAMIN K 3 (menadione). Vitamin K 3 provitamins, after being alkylated in vivo, exhibit the antifibrinolytic activity of vitamin K. Green leafy vegetables, liver, cheese, butter, and egg yolk are good sources of vitamin K.

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