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Epigallocatechin gallate

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Vitamin C

Epigallocatechin

800mg Epigallocatechin-3-Gallate (EGCG) pills AND 250mg Ascorbic Acid (Vitamin C) once daily

800mg microcrystalline cellulose (MCC) pills AND 250mg Ascorbic Acid (Vitamin C) once daily

Epigallocatechin-3-Gallate (EGCG)

Microcrystalline cellulose (MCC)

250mg Ascorbic Acid (Vitamin C) taken one time daily for 12 weeks

Ascorbic Acid (Vitamin C)

This study is a two-arm placebo controlled randomized clinical trial, to assess the effect of a 12-week EGCG intervention on physical frailty compared to placebo in pre-frail older cancer survivors.

Patients in the intervention Arm will receive 800 mg Epigallocatechin-3-Gallate (EGCG) + 250mg Ascorbic Acid

Reducing Frailty for Older Cancer Survivors Using Supplements II

A Phase 2 Randomized Controlled Trial of Epigallocatechin-3-Gallate (EGCG) on Frailty and Inflammation in Older Survivors of Cancer

We will assess the change in SPPB scores from baseline to 12 weeks after baseline in patients in the EGCG intervention arm compared to the placebo arm.

University of Rochester

Assistant Professor

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Vascular Diseases

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Soft Tissue Sarcoma

Intravenous ascorbic acid, 1.5g/kg at an infusion rate not to exceed 250mg/min.

Intravenous administration of up to 1.5gm/kg of ascorbic acid, twice weekly for up to 12-weeks.

Ascorbic acid (vitamin C)

G D Murphy, MD

J Bolt, PhD

The study is designed to determine if high doses of intravenous ascorbic acid (vitamin C) can be effective in managing solid tumor diseases. Secondary goals are determination of any palliative effects and improvement of quality of life of patients.

Ascorbic acid has demonstrated selective cytotoxicity in cancer cells in vitro, while sparing normal cells from its peroxidative effects. This study will examine the effect, if any, of the drug when dosed in patients at a level sufficient to achieve transient serum states of 400mg/dl. Safety of the drug has been shown in a Phase I study when dosed as high as 1.5gm/kg. Patients will be treated twice weekly for 12 weeks (24-cycles) and evaluated for response using RECIST criteria. Patients showing stable disease or objective response will remain on study for up to one year or until absence of measurable disease or disease progression.

Study of High Dose Intravenous (IV) Ascorbic Acid in Measurable Solid Tumor Disease

Phase 2 Study of High Dose Ascorbic Acid in Solid Tumor Disease

Efficacy of treatment will be evaluated at 12-weeks. Efficacy is evaluated using RECIST criteria to determine disease response by CT scan interpretation

Quality of life during treatment will be measured using FACT questionnaires.

Situs Cancer Research Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

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.

60grams of ascorbate given intravenous infusion in 1000ml sterile water.

Kari J Mikines, MD, DsMC

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

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.

Vitamin C as an Anti-cancer Drug

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

Rigshospitalet, Denmark

University of Copenhagen

Copenhagen University Hospital at Herlev

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Reducing Frailty for Older Cancer Survivors Using Supplements II	NCT06068543	Frailty Inflammation	Epigallocatechi... Microcrystallin... Ascorbic Acid (...	65 Years -	University of Rochester
Study of High Dose Intravenous (IV) Ascorbic Acid in Measurable Solid Tumor Disease	NCT01125449	Sarcoma Adenocarcinoma Carcinoma Multiple Myelom... Desmoplastic Sm...	Ascorbic acid (...	18 Years -	Situs Cancer Research Center
Study of High Dose Intravenous (IV) Ascorbic Acid in Measurable Solid Tumor Disease	NCT01125449	Sarcoma Adenocarcinoma Carcinoma Multiple Myelom... Desmoplastic Sm...	Ascorbic acid (...	18 Years -	Situs Cancer Research Center
Vitamin C as an Anti-cancer Drug	NCT01080352	Prostatic Neopl...	Ascorbic Acid (...	18 Years -	Copenhagen University Hospital at Herlev

Spots Global Cancer Trial Database for ascorbic acid (vitamin c)