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

July 26, 2019 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Unknown

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with changes of tumor markers
Time Frame: 12 weeks
CEA, and Ca 199
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Chin-Ying Chen, MD, MHSc, Department of Family Medicine, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2020

Primary Completion (ANTICIPATED)

December 31, 2021

Study Completion (ANTICIPATED)

June 30, 2022

Study Registration Dates

First Submitted

July 22, 2019

First Submitted That Met QC Criteria

July 26, 2019

First Posted (ACTUAL)

July 29, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 29, 2019

Last Update Submitted That Met QC Criteria

July 26, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

2 years after study completed.

IPD Sharing Access Criteria

crystalcychen@ntu.edu.tw

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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