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Trial record 55 of 5190 for:    colon cancer

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
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment Phase
Colon Cancer Stage Iv Drug: Ascorbic Acid Other: Control group Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Clinical trial ( Pilot study)
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

Arm Intervention/treatment
Experimental: The high-dose vitamin C with very low carbohydrate diet group
  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
Drug: Ascorbic Acid
  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
Other Name: VLCD (very low carbohydrate diet) intervention in the first 12 weeks

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Number of participants with changes of tumor markers [ Time Frame: 12 weeks ]
    CEA, and Ca 199



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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,

Information from the National Library of Medicine

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


Contacts
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Contact: Chin-Ying Chen, MD, MHSc 886-2-23123456 crystalcychen@ntu.edu.tw
Contact: Chin-Ying Chen, MD, MHSc 886-2-21323456 crystalcychen@ntu.edu.tw

Locations
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Taiwan
National Taiwan University Hospital Not yet recruiting
Taipei, Taiwan, 100
Contact: Shyr-Chyr Chen, MD, EMBA    886-2-23123456    scchen@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Chin-Ying Chen, MD, MHSc Department of Family Medicine, National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT04035096     History of Changes
Other Study ID Numbers: 201901083MINB
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: 2 years after study completed.
Access Criteria: crystalcychen@ntu.edu.tw

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
high dose vitamin C
very low carbohydrate diet
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Vitamins
Ascorbic Acid
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents