Clinical trial NCT04035096: The Effectiveness of High-dose Intravenous Vitamin c With Very Low Carbohydrate Diet for Terminal Colon Cancer Patients
Official title: The Effectiveness of High-dose Intravenous Vitamin c With Very Low Carbohydrate Diet for Terminal Colon Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Colon Cancer Stage Iv
Keywords: high dose vitamin C
very low carbohydrate diet
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical trial ( Pilot study)
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* stage IV colon cancer
* with KRAS and BRAF mutation

Exclusion Criteria:

* G-6-PD deficiency,
* metastatic kidney disease,
* obstructive uropathy,
* nephrotic syndrome,
* under other alternative medicine treatment or intravenous vitamin treatment,
* pregnant or lactating women,
* impaired renal function with a serum creatinine ≥ 132.6µmol/L(1.5 mg/dL)
* significant fluid retention(pleural effusion, ascites, lower leg edema),
* terminal heart failure,
* incapability to make decision,

Primary outcomes:
measure: Change from baseline by computerized tomography of Chest, abdomen and pelvis
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of participants with changes of tumor markers
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Family Medicine, National Taiwan University Hospital
name: Chin-Ying Chen, MD, MHSc
role: PRINCIPAL_INVESTIGATOR
References: