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Effect of Vitamin C in Autologous Stem Cell Transplantations (VICAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03964688
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : May 28, 2019
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:
In the study the investigators will randomize patients that receive an autologous stem cell transplantation for myeloma or lymphoma for treatment with vitamin C or placebo during 6 weeks. Primary endpoint will be immune recovery.

Condition or disease Intervention/treatment Phase
Myeloma Multiple Lymphoma Drug: Vitamin C Drug: Placebos Phase 2

Detailed Description:

Rationale: Recent studies showed that ascorbic acid (AA) stimulates proliferation and maturation of T lymphocytes and natural killer (NK) cells. Chemotherapy results in depletion of those cells and thereby an increased infection rate. A pilot study showed low levels of AA in the plasma of several patients after chemotherapy followed by autologous stem cell transplantation for hematological malignancies. AA supplementation could be beneficial to the recovery of the immune system in these patients.

Objective: The aim of this study is to examine the effect of vitamin C supplementation on immune recovery in patients with autologous stem cell transplantation. The aim of the run-in phase of the study is to examine the effect of intravenous vitamin C supplementation on plasma concentrations of vitamin C in patients with autologous stem cell transplantation at day 14 in order to be sure that in the intervention study accurate AA plasma levels will be present.

Study design: run-in phase, followed by randomized controlled trial Study population: All participants will be adults (minimally 18 years old) that are planed to receive an autologous stem cell transplantation for multiple myeloma or lymphoma and are recruited at the MUMC+. In total there will be 3 expected (run-in phase) + 44 (randomized controlled trial) participants.

Main study parameters/endpoints: Primary endpoints will be AA plasma level on day 14 (run-in phase) and the day of neutrophil recovery after stem cell transplantation (randomized-controlled phase). Secondary endpoints will be AA leukocyte levels, infection rate, duration of hospital stay, side effects of chemotherapy, overall survival, coagulation parameters, platelet reactivity, fibrinolysis and quality of life.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

AA supplementation could be beneficial for the immune recovery in the participants of this study. The risks associated with participation in this study are low. Vitamin C supplementation is safe and hardly has any documented side effects.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double blind placebo-controlled randomized trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial on the Effect of Vitamin C Supplementation in Autologous Stem Cell Transplantations
Estimated Study Start Date : May 27, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : September 1, 2021


Arm Intervention/treatment
Experimental: Vitamin C
vitamin C intravenous during hospitalization, followed with vitamin C oral
Drug: Vitamin C
vitamin C intravenous during hospitalization, after oral, total 6 weeks.
Other Name: ascorbic acid

Experimental: Placebo
placebo intravenous during hospitalization, followed with placebo oral
Drug: Placebos
placebo intravenous during hospitalization, after oral, total 6 weeks
Other Name: placebo




Primary Outcome Measures :
  1. immune recovery [ Time Frame: day 14-28 ]
    the day of repopulation (return of neutrophil to at least 0.5 × 109/l) after autologous stem cell transplantation.


Secondary Outcome Measures :
  1. AA plasma levels [ Time Frame: day 14 ]
    AA plasma levels

  2. AA leukocyte levels [ Time Frame: day 14 ]
    AA leukocyte levels

  3. Incidence of infections/ neutropenic fever [ Time Frame: day 1-28 ]
    fever and infections during hospitalization

  4. Days of hospitalization [ Time Frame: dag 1-28 ]
    number of days patients are admitted in our hospital

  5. Days with fever (≥ 38.5° C) [ Time Frame: day 1-28 ]
    Amount of days admitted patients have a fever

  6. Incidence of bloodstream infections [ Time Frame: day1-28 ]
    number of bloodstream infections of admitted patients

  7. Quality of life according to the EORTC QLQ-C30 [ Time Frame: Day 0, day 14, day 42 ]
    quality of live questionaire

  8. Overall survival (3 months) [ Time Frame: 3 months ]
    overall survival at 3 months

  9. Relapse rates (3 months) [ Time Frame: 3 months ]
    relapse rate at 3 months

  10. Use of systemic antimicrobial agents (incidence and duration) [ Time Frame: dau 1-28 ]
    use of antibiotics during hospitalization

  11. platelet reactivity [ Time Frame: day 10 ]
    platelet reactivity tests

  12. ROS production [ Time Frame: day 10 ]
    ROS production platelets

  13. platelet mitochondrial dysfunction [ Time Frame: day 10 ]
    platelet mitochondrial function test

  14. number and severity of bleeding episodes during admission [ Time Frame: day 1-28 ]
    number and severity of bleeding episodes during admission



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • written informed consent
  • diagnosis of malignant lymphoma or multiple myeloma
  • require chemotherapy plus autologous stem cell transplantation as standard of care for the disease at that stage
  • central venous catheter in place or planned

Exclusion Criteria:

  • inability to understand the nature and extent of the trial and the procedures required
  • history of kidney stones
  • kidney failure requiring dialysis or eGFR <30 mL/min. (CDK-EPI formula)
  • history of G6PD deficiency
  • life expectancy < 1 month
  • use of immunosuppressive medication other than chemotherapy and corticosteroids

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964688


Contacts
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Contact: Gwendolyn van Gorkom 0031433877026 gwendolyn.van.gorkom@mumc.nl
Contact: Gerard Bos 0031433877026 gerard.bos@mumc.nl

Locations
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Netherlands
MUMC+ Recruiting
Maastricht, Limburg, Netherlands
Contact: Gwendolyn van Gorkom    0031433877026    gwendolyn.van.gorkom@mumc.nl   
Contact: Gerard Bos    0031433877026    gerard.bos@mumc.nl   
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: Gerard Bos Maastricht University Medical Center
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03964688    
Other Study ID Numbers: NL68010.068.18
2018-004135-77 ( EudraCT Number )
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: May 28, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Maastricht University Medical Center:
vitamin C
ascorbate
ascorbic acid
autologous stem cell transplantation
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Ascorbic Acid
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents