Neoplasms

All Conditions

Symptoms and General Pathology

Adenocarcinoma

Inflammation

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

The patient will be evaluated for baseline clinical and laboratory values, and counselled on very low carbohydrate diet.

The patient will be evaluated for baseline clinical and laboratory values, and counselled on normal healthy .

1 : 4 ratio of carbohydrate to fat of the total daily calories intake

Very Low Carbohydrate Diet

Vicky S Budipramana, PhD

Fransiscus Arifin, MD

This study examine the effects of very low carbohydrate diet (in which the calories requirements are mostly from fat) to the level of systemic inflammation (measured by Glasgow Prognostic Score), serum lactate and TNF Alpha levels

This study examine the effects of very low carbohydrate diet (in which the calories requirements are mostly from fat) to the level of systemic inflammation (measured by Glasgow Prognostic Score), serum lactate and TNF Alpha levels. The subjects are colorectal adenocarcinoma patients who were decided by experts to be managed by best supportive care. These patients are not deemed to be suitable for surgical intervention , chemotherapy or radiotherapy anymore. The main treatment is supportive. We would like to examined the effect of very low carbohydrate diet on these patients, in which theoretically tumtor cells of the colorectal adenocarcinoma needed glucose to replicate and increases the systemic inflammation response.

Patients were randomized in to two groups, with very low carbohydrate diet and with normal diet

Care provider are not told whether the patient belongs to intervention or control group

Very Low Carbohydrate Diet Effects to GPS, Serum Lactate and TNF Alpha on Colorectal Cancer

Effect of Very Low Carbohydrate Diet to Glasgow Prognostic Score, Serum Lactate and TNF Alpha on Colorectal Cancer Patients With Best Supportive Care

A score to evaluate systemic inflammation response

Level of Tumor Necrosis Factor Alpha in the blood serum

Dr. Soetomo General Hospital

Digestive System Diseases

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Micronutrients

All Drugs and Chemicals

Vitamins

Herbal and Botanical

Ascorbic Acid

Antioxidants

Protective Agents

Trace Elements

Vitamin C

Cola

1. Initiation of High dose IVC therapy: start with 25g IVC biweekly for one week; 50g IVC biweekly for one week; 75g biweekly for one week.
2. Blood vitamin C level measurement: Confirm the plasma vitamin C level above 350 mg/dl by Arkray company PocketChem VC ( Kyoto, Japan) from the 75g/dose
3. Once the target blood level is confirmed, the dose remains g biweekly for 12 weeks. If the target blood level is below 350mg/dl, the dose will titrate up to 100 g/dose or maximal dose of 1.5g/kg/dose to achieve the target level. The blood vitamin C level will be checked again and record. The final dose will be kept for 12 weeks.
4. The Riordan IVC protocol (Taiwan)
5. Maintenance dose: 75-100g every 2 week will be maintained for additional 12 weeks
6. The infusion schedule change within 2 weeks is accepted with the fixed frequency per week or month
7. VLCD intervention in the first 12 weeks

1. Selection of control group: stage IV colon cancer patients match for sex, age and chemotherapy /target therapy drugs
2. Usual care

1. Start with IVC (intravenous ascorbic acid) 25 g biweekly, 50 g biweekly, and 75 g biweekly. If the target blood level is below 350mg/dl, the dose will titrate up to 100 g/dose or maximal dose of 1.5g/kg/dose to achieve the target level.
2. The final dose will be kept for 12 weeks.
3. Maintenance dose: 75-100g every 2 week will be maintained for additional 12 weeks

Control group

Chin-Ying Chen, MD, MHSc

Shyr-Chyr Chen, MD, EMBA

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.

The Effectiveness of High-dose Intravenous Vitamin c With Very Low Carbohydrate Diet for Terminal Colon Cancer Patients

all the participants will be evaluated by CT of the chest, abdomen and pelvis for possible response to treatment, using the Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria at 12 weeks by the same radiologist, who is blind to the patients group.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Very Low Carbohydrate Diet Effects to GPS, Serum Lactate and TNF Alpha on Colorectal Cancer	NCT03221920	Diet Modificati... Colorectal Aden... Systemic Inflam... TNF Alpha Lactate	Very Low Carboh...	18 Years - 65 Years	Dr. Soetomo General Hospital
The Effectiveness of High-dose Intravenous Vitamin c With Very Low Carbohydrate Diet for Terminal Colon Cancer Patients	NCT04035096	Colon Cancer St...	Ascorbic Acid Control group	20 Years -	National Taiwan University Hospital

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