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Rationale: 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 changing over time of AA levels and the relationship with the immune status after chemotherapy is necessary.
Objective: The aim of this pilot 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. In this way we want to identify the patients were further interventions could be useful and use the data in the development of an intervention study for power calculations and to identify the primary endpoint.
Study design: observational study
Study population: There will be 6 different groups of participants in the study: two groups of patients that receive clinical intensive chemotherapy (acute leukemia and high dose chemotherapy with autologous stem cell rescue), two groups of patients that receive relatively mild chemotherapy in outpatient setting (colon cancer and lung cancer) and two control groups. All participants will be adults and recruited at the MUMC+. In total there will be 150 participants.
Main study parameters/endpoints: Influence of chemotherapy on AA levels in plasma and in leukocytes.
Rationale: 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 changing over time of AA levels and the relationship with the immune status after chemotherapy is necessary.
Objective: The aim of this pilot 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. In this way we want to identify the patients were further interventions could be useful and use the data in the development of an intervention study for power calculations and to identify the primary endpoint.
Study design: observational study
Study population: There will be 6 different groups of participants in the study: two groups of patients that receive clinical intensive chemotherapy (acute leukemia and high dose chemotherapy with autologous stem cell rescue), two groups of patients that receive relatively mild chemotherapy in outpatient setting (colon cancer and lung cancer) and two control groups. All participants will be adults and recruited at the MUMC+. In total there will be 150 participants.
Main study parameters/endpoints: Influence of chemotherapy on AA levels in plasma and in leukocytes.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Acute leukemia | Patients that will receive intensive clinical chemotherapy for acute leukemia or high risk myelodysplasia (RAEB2) Blood withdrawn 5-7 x |
| |
| B: Autologous transplantation | Patients that will receive high dose chemotherapy and autologous stem cell rescue for varies hematological malignancies Blood withdrawn 5-7 x |
| |
| C: controls | Healthy controls, found amongst family members of patients of group A and B Blood withdrawn 5-7 x |
| |
| D: lung cancer | Patients that will receive relatively mild immunosuppressive chemotherapy for lung cancer, that will mostly be in the outpatient setting Blood withdrawn 5-7 x |
| |
| E: colon cancer | Patients that will receive relatively mild immunosuppressive chemotherapy for colon cancer, that will mostly be in the outpatient setting and mostly adjuvant Blood withdrawn 5-7 x |
| |
| F: controls |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood withdrawn | Other | venous blood sampling |
|
| Measure | Description | Time Frame |
|---|---|---|
| AA level in leukocytes | change in AA level during chemotherapy | Baseline to week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| AA level in plasma | Baseline, week 1, week 2, week 3, week 4, week 8 | |
| AA level in leukocytes | Baseline to week 1, to week 3, to week 3 and to week 8 |
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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:
Or family member of a participant (without malignancy or chemotherapy)
Exclusion Criteria:
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Like explained before, there will be 6 different groups of participants:
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| Name | Affiliation | Role |
|---|---|---|
| Gerard Bos, MD, PhD | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MUMC+ | Maastricht | Limburg | Netherlands |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D015470 | Leukemia, Myeloid, Acute |
| D008175 | Lung Neoplasms |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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peripheral blood on AA level and blood count
Healthy controls, found amongst family members of patients of group D and E Blood withdrawn 5-7 x |
|
| D007951 | Leukemia, Myeloid |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |