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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

Tracking Information
First Submitted Date  ICMJE May 9, 2019
First Posted Date  ICMJE May 28, 2019
Last Update Posted Date May 28, 2019
Estimated Study Start Date  ICMJE May 27, 2019
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
  • AA plasma levels [ Time Frame: day 14 ]
    AA plasma levels
  • AA leukocyte levels [ Time Frame: day 14 ]
    AA leukocyte levels
  • Incidence of infections/ neutropenic fever [ Time Frame: day 1-28 ]
    fever and infections during hospitalization
  • Days of hospitalization [ Time Frame: dag 1-28 ]
    number of days patients are admitted in our hospital
  • Days with fever (≥ 38.5° C) [ Time Frame: day 1-28 ]
    Amount of days admitted patients have a fever
  • Incidence of bloodstream infections [ Time Frame: day1-28 ]
    number of bloodstream infections of admitted patients
  • Quality of life according to the EORTC QLQ-C30 [ Time Frame: Day 0, day 14, day 42 ]
    quality of live questionaire
  • Overall survival (3 months) [ Time Frame: 3 months ]
    overall survival at 3 months
  • Relapse rates (3 months) [ Time Frame: 3 months ]
    relapse rate at 3 months
  • Use of systemic antimicrobial agents (incidence and duration) [ Time Frame: dau 1-28 ]
    use of antibiotics during hospitalization
  • platelet reactivity [ Time Frame: day 10 ]
    platelet reactivity tests
  • ROS production [ Time Frame: day 10 ]
    ROS production platelets
  • platelet mitochondrial dysfunction [ Time Frame: day 10 ]
    platelet mitochondrial function test
  • number and severity of bleeding episodes during admission [ Time Frame: day 1-28 ]
    number and severity of bleeding episodes during admission
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Vitamin C in Autologous Stem Cell Transplantations
Official Title  ICMJE Randomized Controlled Trial on the Effect of Vitamin C Supplementation in Autologous Stem Cell Transplantations
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Myeloma Multiple
  • Lymphoma
Intervention  ICMJE
  • Drug: Vitamin C
    vitamin C intravenous during hospitalization, after oral, total 6 weeks.
    Other Name: ascorbic acid
  • Drug: Placebos
    placebo intravenous during hospitalization, after oral, total 6 weeks
    Other Name: placebo
Study Arms  ICMJE
  • Experimental: Vitamin C
    vitamin C intravenous during hospitalization, followed with vitamin C oral
    Intervention: Drug: Vitamin C
  • Experimental: Placebo
    placebo intravenous during hospitalization, followed with placebo oral
    Intervention: Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 24, 2019)
47
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2021
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gwendolyn van Gorkom 0031433877026 gwendolyn.van.gorkom@mumc.nl
Contact: Gerard Bos 0031433877026 gerard.bos@mumc.nl
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03964688
Other Study ID Numbers  ICMJE NL68010.068.18
2018-004135-77 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Maastricht University Medical Center
Study Sponsor  ICMJE Maastricht University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gerard Bos Maastricht University Medical Center
PRS Account Maastricht University Medical Center
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP