Colon Cancer Stage Iv Clinical Trial
Official title:
The Effectiveness of High-dose Intravenous Vitamin c With Very Low Carbohydrate Diet for Terminal Colon Cancer Patients
The purpose is to evaluate the effectiveness of high dose intravenous vitamin C (IVC) therapy plus very low carbohydrate diet (VLCD) for stage IV colon cancer (with KRAS and BRAF mutation ) with or without chemotherapy.
High dose IVC induces pro-oxidant effects, inhibits energy metabolism, acts as cytotoxic
effect, and induces cancer cell apoptosis and necrosis. The recent advance in Warburg effect
makes a new direction in high dose IVC therapy. The Warburg effect is the enhanced conversion
of glucose to lactate observed in tumor cells, even in the presence of normal levels of
oxygen. Converting glucose to lactate, rather than metabolizing it through oxidative
phosphorylation in the mitochondria, is far less efficient as less ATP is generated per unit
of glucose metabolized. Therefore, a high rate of glucose uptake is required to meet
increased energy needs to support rapid tumor progression..
Vitamin C shares very similar structure with glucose. The high-dose IVC gets accessibility to
glucose transporter, with competition to glucose. Having a reduced level of blood sugar seems
to be a necessary parameter to increase IVC's anticancer effectiveness. VLCD with high dose
IVC showed effectiveness in case series.
The investigator's project is a single-centered, clinical trial (pilot study) for stage IV
colon cancer patients with or without chemotherapy. The experimental group will receive high
dose vitamin C 75 or 100g (with blood vitamin C level > 350 mg/dl) in 1000 ml distilled water
in 2-hour infusion, twice per week for 12 weeks. Then maintenance dose is 75-100 g once per 2
weeks for 12 weeks. Very low carbohydrate diet will be executed for the first 12 weeks. The
control group will be matched for age, sex and chemotherapy and target therapy medication.
The control group will receive usual care. The primary outcome will be the response rate by
computerized tomography (CT) of the chest, abdomen and pelvis at 12 weeks and 24 weeks. The
secondary outcome will be the improvement of tumor markers (CEA and Ca199).
This is the first clinical trial of IVC therapy with VLCD for stage IV colon cancer in Taiwan
and in the world. This innovation will give us a primitive answer on the effectiveness of IVC
therapy with VLCD for cancers. Vitamin C is a cheap and harmless therapy. The study result
will open a door for alternative cancer treatment.
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