Ignite Creation Date:
2024-05-06 @ 1:28 PM
Last Modification Date:
2024-10-26 @ 1:15 PM
Study NCT ID:
NCT04035096
Status:
UNKNOWN
Last Update Posted:
2019-07-29
First Post:
2019-07-22
Brief Title:
The Effectiveness of High-dose Intravenous Vitamin c With Very Low Carbohydrate Diet for Terminal Colon Cancer Patients
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
The Effectiveness of High-dose Intravenous Vitamin c With Very Low Carbohydrate Diet for Terminal Colon Cancer Patients
Status:
UNKNOWN
Status Verified Date:
2019-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 IVCs anticancer effectiveness VLCD with high dose IVC showed effectiveness in case series
The investigators 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 mgdl 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
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 IVCs anticancer effectiveness VLCD with high dose IVC showed effectiveness in case series
The investigators 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 mgdl 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None