Clinical trial · Observational
Changing Over Time of Ascorbic Acid After Chemotherapy
The Changing Over Time of Ascorbic Acid After Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Lung | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Leukemia (Both ALL and AML) | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blood withdrawn | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- label
- A: Acute leukemia
- description
- Patients that will receive intensive clinical chemotherapy for acute leukemia or high risk myelodysplasia (RAEB2) Blood withdrawn 5-7 x
- interventionNames
- Other: blood withdrawn
- label
- B: Autologous transplantation
- description
- Patients that will receive high dose chemotherapy and autologous stem cell rescue for varies hematological malignancies Blood withdrawn 5-7 x
- interventionNames
- Other: blood withdrawn
- label
- C: controls
- description
- Healthy controls, found amongst family members of patients of group A and B Blood withdrawn 5-7 x
- interventionNames
- Other: blood withdrawn
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 * Lung cancer * Colon cancer * 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
References
Publications (0)
Data not yet available