Phase I Trial of High-Dose Vitamin C with Gemcitabine in Pancreatic Cancer

Phase I Trial of High-Dose Vitamin C with Gemcitabine in Pancreatic Cancer

IV infusion of high-dose vitamin C alongside gemcitabine chemotherapy

Dr. Kumar’s Take

This small safety study gave patients with advanced pancreatic cancer very high doses of vitamin C by IV, alongside standard gemcitabine chemotherapy. It was encouraging to see very few extra side effects and early signs that patients lived longer than usual. This opens a new path to support chemotherapy with a common nutrient.

Key Takeaways

High-dose IV vitamin C (50–125 g twice weekly) with gemcitabine caused no serious extra side effects.
Mild side effects included diarrhea and dry mouth that resolved the same day.
On average, tumors took about 6 months to grow again and patients lived about 13 months in total.
Blood tests showed no increase in overall oxidative stress; key antioxidant levels stayed stable.

Actionable tip

Ask your healthcare team about ongoing trials of high-dose vitamin C infusions alongside chemotherapy to see if you might qualify.

Brief Summary

A phase I trial enrolled nine patients with stage IV pancreatic cancer. Each patient received high-dose IV vitamin C (escalating from 15 g up to 50–125 g per infusion) twice a week, along with standard weekly gemcitabine chemotherapy. Researchers checked for side effects, measured blood markers of vitamin C and oxidative stress, and used scans to follow tumor changes. No dose-limiting toxicities linked to vitamin C were found, and early survival times looked better than historical results with chemotherapy alone.

Study Design

  • Enrolled nine adults with unresectable or metastatic pancreatic adenocarcinoma
  • IV vitamin C given twice weekly, starting at 15 g and increasing to reach blood levels ≥350 mg/dL
  • Standard gemcitabine (chemotherapy) given once a week for three weeks each four-week cycle
  • Safety monitored with blood tests, scans, and standard side-effect criteria

Results

  • All nine patients tolerated vitamin C infusions with no dose-limiting toxicities
  • Mild side effects: diarrhea in 4 patients and dry mouth in 6 patients, all resolved the same day
  • Average time until tumor growth was 26 weeks; average overall survival was 13 months
  • Blood markers of oxidative stress decreased, and antioxidant levels in red blood cells stayed normal

How High-Dose Vitamin C Supports Cancer Treatment

At very high doses, vitamin C can produce small amounts of hydrogen peroxide in the area around cancer cells. This extra oxidative stress helps make chemotherapy more effective at killing cancer cells, while normal cells remain protected by the body’s own antioxidants.

Vitamin C Redox and Brain Health: Metabolism and Redox State in the Brain – Reviews ascorbate’s neuronal redox regulation and support of neurotransmitter synthesis.

Regulation of Collagen Synthesis by Ascorbic Acid – Chronicles how vitamin C facilitates collagen biosynthesis through enzymatic hydroxylation.

High-Dose Intravenous Vitamin C with Chemotherapy in Ovarian Cancer – Demonstrates improved chemosensitivity in ovarian cancer with parenteral ascorbate.

Potential Mechanisms of Action for Vitamin C in Cancer: Reviewing the Evidence – Explores ascorbate’s impact on cancer cell redox homeostasis and apoptosis pathways.

Role of Vitamin C in Carnitine Biosynthesis – Highlights ascorbate’s coenzyme role in converting trimethyllysine to carnitine for energy metabolism.

Frequently Asked Questions

What is pharmacological ascorbate?

It is the use of very high doses of vitamin C given by IV to reach blood levels much higher than what you get from diet or pills.

Does high-dose vitamin C replace chemotherapy?

No. This study added vitamin C to standard gemcitabine chemotherapy. It was not tested alone and most experts view it as a supporting treatment.

Are there serious side effects of IV vitamin C?

In this trial, no serious side effects were linked to vitamin C. The most common mild effects were diarrhea and dry mouth.

How can I find a trial using vitamin C and chemotherapy?

Search clinicaltrials.gov for terms like “ascorbate” and “gemcitabine,” or ask your oncologist if any local trials are open.

Conclusion

This phase I trial shows that high-dose IV vitamin C can be safely added to gemcitabine chemotherapy, with minimal extra side effects and encouraging early survival results.

Read the full study here