adults (minimally 18 years old) that are planed to receive an autologous stem cell transplantation for a hematological malignancy (myeloma or lymphoma)
Conditions
Interventions
Trade Name: ascorbic acid
Product Name: ascorbic acid
Pharmaceutical Form:
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Trade Name: ascorbic acid
Prod
Sponsors
MUMC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 18 years or older - written informed consent - diagnosis of malignant lymphoma or multiple myeloma - require chemotherapy plus autologous stem cell transplantation - central venous catheter in place or planned Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 34 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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 - active vitamin C supplementation other than normal daily multivitamin use - any concurrent medical or psychiatric condition or disease that is likely to interfere with the study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to examine the effect of vitamin C supplementation on immune recovery and on plasma and leukocyte concentrations of vitamin C in patients with autologous stem cell transplantation. ;Primary end point(s): The main study endpoints will be the plasma AA level at day 14 and the day of repopulation (return of neutrophil to at least 0.5 × 109/l) after autologous stem cell transplantation.;Timepoint(s) of evaluation of this end point: Day 14 and day of neutrophile recovery;Secondary Objective: - To study the effect of AA supplementation on subpopulations of lymphocytes - To investigate the effect of vitamin C on platelet reactivity, mitochondrial dysfunction and ROS production in CIT patients - To investigate the effect of vitamin C on coagulation parameters and fibrinolysis in CIT patients - To study infection rate after autologous stem cell transplantation with and without AA supplementation - To study duration of hospital stay after autologous stem cell transplantation with and without AA supplementation - To study overall survival after autologous stem cell transplantation with and without AA supplementation - To study side effects of chemotherapy after autologous stem cell transplantation with and without AA supplementation - To study quality of life after autologous stem cell transplantation with and without AA supplementation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - AA plasma levels at other time points - AA leukocyte levels - Incidence of infections/ neutropenic fever - Days of hospitalization - Days with fever (= 38.5° C) - Mean daily morning temperature - Incidence of bloodstream infections i.e. bacteremia - Type of bloodstream infections - Quality of life according to the EORTC QLQ-C30 - Short term overall survival (3 months) - Use of systemic antimicrobial agents (incidence and duration) - platelet reactivity - ROS production - platelet mitochondrial dysfunction - coagulation parameters - tPA-ROTEM and fibrinolytic parameters - number and severity of bleeding episodes during admission ;Timepoint(s) of evaluation of this end point: Untill day 42 | — |
Countries
Netherlands
Contacts
Public ContactG van Gorkom
MUMC
Outcome results
None listed