The aim of this study is to evaluate the changing over time of AA levels in plasma and in leukocytes before and during chemotherapy treatment for several different groups of patients and compare that to healthy controls.
ID
Source
Brief title
Condition
- Leukaemias
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Influence of chemotherapy on AA levels in plasma and in leukocytes.
Secondary outcome
Relation between AA levels and immune cells.
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 for
hematological malignancies. AA suppletion could be beneficial to the recovery
of the immune system in these patients. But before an intervention study can be
undertaken, further understanding of kinetics of AA levels and the relationship
with the immune status after chemotherapy is necessary.
Study objective
The aim of this study is to evaluate the changing over time of AA levels in
plasma and in leukocytes before and during chemotherapy treatment for several
different groups of patients and compare that to healthy controls.
Study design
Observational study
Study burden and risks
If participants really have a lack of AA after chemotherapy, AA supplementation
could be beneficial for the immune recovery in many future patients on
chemotherapy. However, the participants cannot benefit yet, because this study
does not interfere with current clinical practice. The risks associated with
participation in this study are low. Venous blood sampling is performed by
skilled and experienced laboratory technicians. For the study, only a small
amount of blood, 5 to 7 times 17 ml is needed. Therefore no harm can be
expected. Blood withdrawal could result in a hematoma, but this is usually not
harmful. Bleedings from the blood withdrawal are usually negligible.
P. debeyelaan 25 P. debeyelaan 25
Maastricht 6229 HX
NL
P. debeyelaan 25 P. debeyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
- 18 years or older
- written informed consent
- Require chemotherapy and will start this treatment in less than 1 month after registration for any of the following diseases:
• Acute leukemia or high risk myelodysplasia (RAEB2)
• Hematological disease requiring autologous stem cell transplantation after chemotherapy
- Or family member of a participant (without malignancy or chemotherapy)
Exclusion criteria
- recent (<1 month ago) chemotherapy
- kidney failure requiring dialysis
- life expectancy < 1 month
- use of immunosuppressive medication other than chemotherapy and corticosteroids
- active vitamin C suppletion
Design
Recruitment
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 |
|---|---|
| ClinicalTrials.gov | NCT02931942 |
| CCMO | NL53414.068.15 |