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…
ID
Source
Brief title
Condition
- Lymphomas non-Hodgkin's unspecified histology
- Haematopoietic neoplasms (excl leukaemias and lymphomas)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Recent studies showed that ascorbic acid (AA) stimulates proliferation and
maturation of T lymphocytes and 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.
Study 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
Intervention
Vitamin C intravenous during 2-3 weeks followed by oral vitamin C for a total
of six weeks.
Study burden and risks
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.
Dorpstraat 37
Maastricht 6227HJ
NL
Dorpstraat 37
Maastricht 6227HJ
NL
Listed location countries
Age
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
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.
- Patients that are eligible after transplantation for a follow up in the
out-patient setting and want to use this option.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-004135-77-NL |
| CCMO | NL68010.068.18 |