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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Copenhagen University Hospital at Herlev

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rigshospitalet, Denmark
University of Copenhagen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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