Vitamin C for Myelodysplastic Syndrome

(EVITA Trial)

Recruiting at 4 trial locations

Overseen By Stine Ulrik Mikkelsen, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rigshospitalet, Denmark

Must not be taking: Vitamin C

Disqualifiers: Chemotherapy, Active treatment, Allergic reactions, others

Compensation: Varies

Number of Visits: 3

Duration: 12 months

109 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must stop any vitamin C supplements or multivitamins at least 24 hours before the study begins.

What data supports the effectiveness of the drug Vitamin C for Myelodysplastic Syndrome?

Research suggests that Vitamin C can decrease the growth and survival of myelodysplastic syndrome cells by inducing cell death, which may make it a promising treatment option. Additionally, Vitamin C is important for certain cellular processes and may help correct deficiencies in patients with myeloid cancers, potentially affecting disease progression. ^{1 2 3 4 5}

Is Vitamin C safe for use in humans?

There is limited safety data on the use of Vitamin C, especially when combined with chemotherapy, but it is generally considered safe as it is an essential vitamin for humans. ^{1 2 4 6 7}

How does the drug Vitamin C differ from other treatments for Myelodysplastic Syndrome?

Vitamin C is unique in treating Myelodysplastic Syndrome because it induces cell death through apoptosis (a process of programmed cell death) by increasing oxidative stress in the cells, which is different from traditional chemotherapy drugs. It also acts as a co-factor for enzymes involved in epigenetic regulation, potentially slowing down the progression of the disease. ^{1 2 4 7 8}

What is the purpose of this trial?

This trial tests if taking vitamin C daily can help patients with certain low-risk blood cancers. These patients often have low vitamin C levels, which might affect their DNA. By boosting vitamin C, the study aims to see if it can improve DNA health and slow cancer progression. Vitamin C has been studied for its potential effects on cancer prevention and treatment, with some evidence suggesting it may improve quality of life and defense reactions in cancer patients.

Research Team

Kirsten Grønbæk, Professor

Principal Investigator

Rigshospitalet, Denmark

Eligibility Criteria

This trial is for adults with certain low-risk blood disorders like CCUS, MDS, or CMML-0/1. They must have specific types of low blood counts and genetic markers without other causes for their condition. People can't join if they've had recent chemo, are on active treatment (except some supportive care), are allergic to vitamin C, or can't follow the study rules.

Inclusion Criteria

I have low blood counts for more than 6 months, not caused by common conditions or other cancers.

I have CMML-0 or -1 with a specific gene mutation linked to my cancer.

My MDS is low-risk with a bone marrow blast percentage under 5.

Exclusion Criteria

Unwillingness to comply with all aspects of the protocol

I am willing to stop taking vitamin C and multivitamins 24 hours before tests.

I have not had chemotherapy in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either vitamin C or placebo for 12 months to assess changes in epigenetic markers and disease progression

12 months

Visits every 3 months for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Placebo
• Vitamin C (ascorbic acid)

Trial Overview The study tests if oral vitamin C can reverse epigenetic changes in patients with low-risk myeloid malignancies. Participants will be randomly given either vitamin C or a placebo without knowing which one they're getting to see if it should be added to standard treatments.

Participant Groups

Group I: Vitamin C Experimental Treatment 1 Intervention

Vitamin C (ascorbic acid) 500 mg/capsule. Ingestion of 2 capsules (1000 mg) daily for 12 months.

Group II: Placebo Placebo Group 1 Intervention

Placebo capsule. Ingestion of 2 capsules daily for 12 months. Placebo will be prepared as capsules that look and taste identical to the vitamin C supplement capsules. The content of the placebo is lactose, potato starch, gelatin, magnesium stearate, and talc.

Who Is Running the Clinical Trial?

Rigshospitalet, Denmark

Lead Sponsor

Trials

1,343

Recruited

2,453,000+

Van Andel Institute - Stand Up To Cancer Epigenetics Dream Team

Collaborator

Trials

2

Recruited

310+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+

Imperial College London

Collaborator

Trials

1,052

Recruited

15,030,000+

University of Copenhagen

Collaborator

Trials

963

Recruited

13,350,000+

Odense University Hospital

Collaborator

Trials

808

Recruited

1,272,000+

Technical University of Denmark

Collaborator

Trials

87

Recruited

31,100+

Aalborg University Hospital

Collaborator

Trials

406

Recruited

575,000+

Van Andel Research Institute

Collaborator

Trials

28

Recruited

5,200+

Findings from Research

In a study involving 14 patients with stage IV pancreatic cancer, intravenous ascorbic acid was administered alongside standard chemotherapy (gemcitabine and erlotinib) for eight weeks, with nine patients completing the treatment.

The addition of ascorbic acid did not increase toxicity compared to standard treatment alone, and seven out of nine patients showed stable disease, indicating potential benefits that warrant further investigation in a phase II study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I evaluation of intravenous ascorbic acid in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer. Monti, DA., Mitchell, E., Bazzan, AJ., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Oxidative stress mediates apoptotic effects of ascorbate and dehydroascorbate in human Myelodysplasia cells in vitro. [2013]

2. England pubmed.ncbi.nlm.nih.gov

Depletion of L-ascorbic acid alternating with its supplementation in the treatment of patients with acute myeloid leukemia or myelodysplastic syndromes. [2016]

3. Germany pubmed.ncbi.nlm.nih.gov

Oral vitamin C supplementation to patients with myeloid cancer on azacitidine treatment: Normalization of plasma vitamin C induces epigenetic changes. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Clinical and molecular characteristics associated with Vitamin C deficiency in myeloid malignancies; real world data from a prospective cohort. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Vitamin C in leukemia and preleukemia cell growth. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Phase I evaluation of intravenous ascorbic acid in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer. [2022]

7. China pubmed.ncbi.nlm.nih.gov

[Inhibitory Effect of Ascorbic Acid on Myelodysplastic Syndrome Cells and Its Mechanism]. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

New uses for old vitamins. The treatment of myelodysplastic disorders. [2019]