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

NCT04035096 | Unknown Phase 1

• 1 other identifier: 201901083MINB
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer Stage Iv

Keywords

high dose vitamin C; very low carbohydrate diet

Outcome Measures

Primary Outcomes (1)

• Change from baseline by computerized tomography of Chest, abdomen and pelvis

  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 Outcomes (1)

• Number of participants with changes of tumor markers

  12 weeks

Study Arms (2)

The high-dose vitamin C with very low carbohydrate diet group

EXPERIMENTAL

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

The control group

ACTIVE COMPARATOR

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

Interventions

Ascorbic Acid DRUG

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

Also known as: VLCD (very low carbohydrate diet) intervention in the first 12 weeks

The high-dose vitamin C with very low carbohydrate diet group

Control group OTHER

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

The control group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stage IV colon cancer
• with KRAS and BRAF mutation

You may not qualify if:

• 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,

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Ascorbic Acid; Methods; Control Groups

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design

Study Officials

• Chin-Ying Chen, MD, MHSc

  Department of Family Medicine, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chin-Ying Chen, MD, MHSc

CONTACT

886-2-23123456; crystalcychen@ntu.edu.tw

Chin-Ying Chen, MD, MHSc

CONTACT

886-2-21323456; crystalcychen@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinical trial ( Pilot study)

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: July 29, 2019
• Study Start: January 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: July 29, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 2 years after study completed.
• Access Criteria: crystalcychen@ntu.edu.tw

Locations

TW (1)