The Effectiveness of High-dose Intravenous Vitamin c With Very Low Carbohydrate Diet for Terminal Colon Cancer Patients
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|ClinicalTrials.gov Identifier: NCT04035096|
Recruitment Status : Not yet recruiting
First Posted : July 29, 2019
Last Update Posted : July 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer Stage Iv||Drug: Ascorbic Acid Other: Control group||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Clinical trial ( Pilot study)|
|Masking:||None (Open Label)|
|Official Title:||The Effectiveness of High-dose Intravenous Vitamin c With Very Low Carbohydrate Diet for Terminal Colon Cancer Patients|
|Estimated Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||June 30, 2022|
Experimental: The high-dose vitamin C with very low carbohydrate diet group
Drug: Ascorbic Acid
Other Name: VLCD (very low carbohydrate diet) intervention in the first 12 weeks
Active Comparator: The control group
Other: Control group
- Change from baseline by computerized tomography of Chest, abdomen and pelvis [ Time Frame: 12 weeks ]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.
- Number of participants with changes of tumor markers [ Time Frame: 12 weeks ]CEA, and Ca 199
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): NCT04035096
|Contact: Chin-Ying Chen, MD, MHScfirstname.lastname@example.org|
|Contact: Chin-Ying Chen, MD, MHScemail@example.com|
|National Taiwan University Hospital||Not yet recruiting|
|Taipei, Taiwan, 100|
|Contact: Shyr-Chyr Chen, MD, EMBA 886-2-23123456 firstname.lastname@example.org|
|Principal Investigator:||Chin-Ying Chen, MD, MHSc||Department of Family Medicine, National Taiwan University Hospital|