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VICAST: Effect of Vitamin C in Autologous Stem Cell Transplantations

Sponsor
Maastricht University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03964688
Collaborator
(none)
47
Enrollment
1
Location
2
Arms
26.7
Actual Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
47 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
double blind placebo-controlled randomized trialdouble 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
Actual Study Start Date :
Dec 10, 2019
Actual Primary Completion Date :
Mar 1, 2022
Actual Study Completion Date :
Mar 1, 2022

Arms and Interventions

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 Names:
  • ascorbic acid

    		•
    Experimental: Placebo

    placebo intravenous during hospitalization, followed with placebo oral

    Drug: Placebos
    placebo intravenous during hospitalization, after oral, total 6 weeks
    Other Names:
  • placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. immune recovery [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 [day 14]

      AA plasma levels

    2. AA leukocyte levels [day 14]

      AA leukocyte levels

    3. Incidence of infections/ neutropenic fever [day 1-28]

      fever and infections during hospitalization

    4. Days of hospitalization [dag 1-28]

      number of days patients are admitted in our hospital

    5. Days with fever (≥ 38.5° C) [day 1-28]

      Amount of days admitted patients have a fever

    6. Incidence of bloodstream infections [day1-28]

      number of bloodstream infections of admitted patients

    7. Quality of life according to the EORTC QLQ-C30 [Day 0, day 14, day 42]

      quality of live questionaire

    8. Overall survival (3 months) [3 months]

      overall survival at 3 months

    9. Relapse rates (3 months) [3 months]

      relapse rate at 3 months

    10. Use of systemic antimicrobial agents (incidence and duration) [dau 1-28]

      use of antibiotics during hospitalization

    11. platelet reactivity [day 10]

      platelet reactivity tests

    12. ROS production [day 10]

      ROS production platelets

    13. platelet mitochondrial dysfunction [day 10]

      platelet mitochondrial function test

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

      number and severity of bleeding episodes during admission

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MUMC+ Maastricht Limburg Netherlands

    Sponsors and Collaborators

    • Maastricht University Medical Center

    Investigators

    • Principal Investigator: Gerard Bos, Maastricht University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Maastricht University Medical Center
    ClinicalTrials.gov Identifier:
    NCT03964688
    Other Study ID Numbers:
    • NL68010.068.18
    • 2018-004135-77
    First Posted:
    May 28, 2019
    Last Update Posted:
    Apr 20, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Multiple Myeloma
    Neoplasms, Plasma Cell
    Ascorbic Acid

    Study Results

    No Results Posted as of Apr 20, 2022