Clinical trial · Interventional
The Effectiveness of High-dose Intravenous Vitamin c With Very Low Carbohydrate Diet for Terminal Colon Cancer Patients
NCT04035096CI-TRIAL-00039774unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer Stage Iv | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ascorbic Acid | Drug | — | UNRESOLVED |
| Control group | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- The high-dose vitamin C with very low carbohydrate diet group
- description
- 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
- interventionNames
- Drug: Ascorbic Acid
- type
- ACTIVE_COMPARATOR
- label
- The control group
- description
- 1. Selection of control group: stage IV colon cancer patients match for sex, age and chemotherapy /target therapy drugs 2. Usual care
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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,
References
Publications (0)
Data not yet available
No reference posted for this study.