109 Participants Needed

Vitamin C for Myelodysplastic Syndrome

(EVITA Trial)

Recruiting at 4 trial locations
KG
SU
Overseen ByStine Ulrik Mikkelsen, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Rigshospitalet, Denmark

What You Need to Know Before You Apply

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.

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.

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.12345

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.13456

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.13578

Who Is on the Research Team?

KG

Kirsten Grønbæk, Professor

Principal Investigator

Rigshospitalet, Denmark

Are You a Good Fit for This Trial?

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.
See 3 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Vitamin CExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

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+

Published Research Related to This Trial

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.
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]

Citations

Oxidative stress mediates apoptotic effects of ascorbate and dehydroascorbate in human Myelodysplasia cells in vitro. [2013]
Depletion of L-ascorbic acid alternating with its supplementation in the treatment of patients with acute myeloid leukemia or myelodysplastic syndromes. [2016]
Oral vitamin C supplementation to patients with myeloid cancer on azacitidine treatment: Normalization of plasma vitamin C induces epigenetic changes. [2021]
Clinical and molecular characteristics associated with Vitamin C deficiency in myeloid malignancies; real world data from a prospective cohort. [2023]
Vitamin C in leukemia and preleukemia cell growth. [2013]
Phase I evaluation of intravenous ascorbic acid in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer. [2022]
[Inhibitory Effect of Ascorbic Acid on Myelodysplastic Syndrome Cells and Its Mechanism]. [2021]
New uses for old vitamins. The treatment of myelodysplastic disorders. [2019]
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