Effect of Vitamin C in Autologous Stem Cell Transplantations (VICAST)
Primary Purpose
Myeloma Multiple, Lymphoma
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Vitamin C
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Myeloma Multiple focused on measuring vitamin C, ascorbate, ascorbic acid, autologous stem cell transplantation
Eligibility 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
Sites / Locations
- MUMC+
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Vitamin C
Placebo
Arm Description
vitamin C intravenous during hospitalization, followed with vitamin C oral
placebo intravenous during hospitalization, followed with placebo oral
Outcomes
Primary Outcome Measures
immune recovery
the day of repopulation (return of neutrophil to at least 0.5 × 109/l) after autologous stem cell transplantation.
Secondary Outcome Measures
AA plasma levels
AA plasma levels
AA leukocyte levels
AA leukocyte levels
Incidence of infections/ neutropenic fever
fever and infections during hospitalization
Days of hospitalization
number of days patients are admitted in our hospital
Days with fever (≥ 38.5° C)
Amount of days admitted patients have a fever
Incidence of bloodstream infections
number of bloodstream infections of admitted patients
Quality of life according to the EORTC QLQ-C30
quality of live questionaire
Overall survival (3 months)
overall survival at 3 months
Relapse rates (3 months)
relapse rate at 3 months
Use of systemic antimicrobial agents (incidence and duration)
use of antibiotics during hospitalization
platelet reactivity
platelet reactivity tests
ROS production
ROS production platelets
platelet mitochondrial dysfunction
platelet mitochondrial function test
number and severity of bleeding episodes during admission
number and severity of bleeding episodes during admission
Full Information
NCT ID
NCT03964688
First Posted
May 9, 2019
Last Updated
April 19, 2022
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03964688
Brief Title
Effect of Vitamin C in Autologous Stem Cell Transplantations
Acronym
VICAST
Official Title
Randomized Controlled Trial on the Effect of Vitamin C Supplementation in Autologous Stem Cell Transplantations
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myeloma Multiple, Lymphoma
Keywords
vitamin C, ascorbate, ascorbic acid, autologous stem cell transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
double blind placebo-controlled randomized trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin C
Arm Type
Experimental
Arm Description
vitamin C intravenous during hospitalization, followed with vitamin C oral
Arm Title
Placebo
Arm Type
Experimental
Arm Description
placebo intravenous during hospitalization, followed with placebo oral
Intervention Type
Drug
Intervention Name(s)
Vitamin C
Other Intervention Name(s)
ascorbic acid
Intervention Description
vitamin C intravenous during hospitalization, after oral, total 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
placebo
Intervention Description
placebo intravenous during hospitalization, after oral, total 6 weeks
Primary Outcome Measure Information:
Title
immune recovery
Description
the day of repopulation (return of neutrophil to at least 0.5 × 109/l) after autologous stem cell transplantation.
Time Frame
day 14-28
Secondary Outcome Measure Information:
Title
AA plasma levels
Description
AA plasma levels
Time Frame
day 14
Title
AA leukocyte levels
Description
AA leukocyte levels
Time Frame
day 14
Title
Incidence of infections/ neutropenic fever
Description
fever and infections during hospitalization
Time Frame
day 1-28
Title
Days of hospitalization
Description
number of days patients are admitted in our hospital
Time Frame
dag 1-28
Title
Days with fever (≥ 38.5° C)
Description
Amount of days admitted patients have a fever
Time Frame
day 1-28
Title
Incidence of bloodstream infections
Description
number of bloodstream infections of admitted patients
Time Frame
day1-28
Title
Quality of life according to the EORTC QLQ-C30
Description
quality of live questionaire
Time Frame
Day 0, day 14, day 42
Title
Overall survival (3 months)
Description
overall survival at 3 months
Time Frame
3 months
Title
Relapse rates (3 months)
Description
relapse rate at 3 months
Time Frame
3 months
Title
Use of systemic antimicrobial agents (incidence and duration)
Description
use of antibiotics during hospitalization
Time Frame
dau 1-28
Title
platelet reactivity
Description
platelet reactivity tests
Time Frame
day 10
Title
ROS production
Description
ROS production platelets
Time Frame
day 10
Title
platelet mitochondrial dysfunction
Description
platelet mitochondrial function test
Time Frame
day 10
Title
number and severity of bleeding episodes during admission
Description
number and severity of bleeding episodes during admission
Time Frame
day 1-28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerard Bos
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MUMC+
City
Maastricht
State/Province
Limburg
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Vitamin C in Autologous Stem Cell Transplantations
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