Vitamin C as an Anti-cancer Drug

March 25, 2015 updated by: Copenhagen University Hospital at Herlev

Evaluation of Cytotoxicity and Genetic Changes of High Dose Vitamin C Infusions in Castration Resistant Metastatic Human Prostate Cancer

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 bone specific alkaline phosphates, oxidative DNA-damage, PINP, 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 (efficacy evaluation when 20 subjects have been evaluated for extension arm)
  • Each subject receives a weekly infusion of 60 grams vitamin c (in the form of ascorbate) for 12 to 20 weeks

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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, 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 Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Castration resistant metastatic prostate cancer (bony or visceral metastases)
  • Gleason sum > 6
  • PSA > 10 ng/ml
  • ECOG < 3
  • Prior orchidectomy or LHRH antagonist/agonist treatment
  • Must give informed content

Exclusion Criteria:

  • Synchronous active cancer (skin cancer excluded)
  • Prior chemotherapy
  • History of oxalate renal stones
  • Glucose-6-phosphate dehydrogenase deficiency
  • Impaired renal function (creatinine > 200micromoles/L
  • Haemochromatosis
  • Cardiac disease (NYHA > 2, CSS > 2, recent AMI (less than 6 months)
  • Recent major surgery (less than 4 weeks before inclusion and more than 2 days of admittance time)
  • Prior intended curative treatment of prostate cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin C treatment

Each subjects receive 12 weeks of 1 weekly treatment with intravenous vitamin c.

5grams are given at week 1, 30 grams at week 2 and 60 grams at week 3-12. If eligibility criteria are met the subject may continue with 1 weekly vitamin c treatment of 60 grams at week 13-20.
Drug: Ascorbic Acid (Vitamin C)
60grams of ascorbate given intravenous infusion in 1000ml sterile water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PSA changes after 12-20 weeks of treatment
Time Frame: 12, 20 and 26 weeks
12, 20 and 26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Bone metastases changes
Time Frame: 12, 26 and 52 weeks
12, 26 and 52 weeks
bALP changes
Time Frame: 12, 20, 26 and 52 weeks
12, 20, 26 and 52 weeks
NTX changes
Time Frame: 12, 20, 26 and 52 weeks
12, 20, 26 and 52 weeks
PINP changes
Time Frame: 12, 20, 26 and 52 weeks
12, 20, 26 and 52 weeks
8-oxo-guanine changes
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen University Hospital at Herlev

Collaborators

Rigshospitalet, Denmark
University of Copenhagen

Investigators

  • Principal Investigator: Kari J Mikines, MD, DsMC, Copenhagen University Hospital at Herlev

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

March 3, 2010

First Submitted That Met QC Criteria

March 3, 2010

First Posted (Estimate)

March 4, 2010

Study Record Updates

Last Update Posted (Estimate)

March 26, 2015

Last Update Submitted That Met QC Criteria

March 25, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-008692-33

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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