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

NCT04035096 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-07-29

No results posted yet for this study

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.

Conditions

  • Colon Cancer Stage Iv

Interventions

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

Control group

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

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2021-12-31
Completion
2022-06-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04035096 on ClinicalTrials.gov