Vitamin C as an Anti-cancer Drug
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|ClinicalTrials.gov Identifier: NCT01080352|
Recruitment Status : Completed
First Posted : March 4, 2010
Last Update Posted : March 26, 2015
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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.
- Prostate specific antigen (PSA) changes after 12 to 20 weekly vitamin c infusions
- 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
- 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
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms||Drug: Ascorbic Acid (Vitamin C)||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Cytotoxicity and Genetic Changes of High Dose Vitamin C Infusions in Castration Resistant Metastatic Human Prostate Cancer|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||March 2015|
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.
- PSA changes after 12-20 weeks of treatment [ Time Frame: 12, 20 and 26 weeks ]
- Bone metastases changes [ Time Frame: 12, 26 and 52 weeks ]
- bALP changes [ Time Frame: 12, 20, 26 and 52 weeks ]
- NTX changes [ Time Frame: 12, 20, 26 and 52 weeks ]
- PINP changes [ Time Frame: 12, 20, 26 and 52 weeks ]
- 8-oxo-guanine changes [ Time Frame: 12 weeks ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- 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
- Synchronous active cancer (skin cancer excluded)
- Prior chemotherapy
- History of oxalate renal stones
- Glucose-6-phosphate dehydrogenase deficiency
- Impaired renal function (creatinine > 200micromoles/L
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01080352
|Departmen of Urology, Copenhagen University Hospital at Herlev|
|Herlev, DK, Denmark, 2730|
|Principal Investigator:||Kari J Mikines, MD, DsMC||Copenhagen University Hospital at Herlev|
|Responsible Party:||Copenhagen University Hospital at Herlev|
|Other Study ID Numbers:||
|First Posted:||March 4, 2010 Key Record Dates|
|Last Update Posted:||March 26, 2015|
|Last Verified:||March 2015|
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Male Urogenital Diseases
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action