Leukemia (Both ALL and AML)NCT02931942
Changing Over Time of Ascorbic Acid After Chemotherapy
An observational study of Leukemia (Both ALL and AML) and Cancer of Lung, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Leukemia (Both ALL and AML), Cancer of Lung, Myeloma
- What is being tested?
- blood withdrawn
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2016to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Like explained before, there will be 6 different groups of participants: 1. Patients that will receive intensive clinical chemotherapy for acute leukemia or high risk myelodysplasia (RAEB2) 2. Patients that will receive high dose chemotherapy and autologous stem cell rescue for varies hematological malignancies 3. Patients that will receive relatively mild immunosuppressive chemotherapy for lung cancer, that will mostly be in the outpatient setting 4. Patients that will receive relatively mild immunosuppressive chemotherapy for colon cancer, that will mostly be in the outpatient setting and mostly adjuvant 5. Healthy controls, found amongst family members of patients of group 1 and 2 6. Healthy controls, found amongst family members of patients of group 3 and 4
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Changing Over Time of Ascorbic Acid After Chemotherapy
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Leukemia (Both ALL and AML), Cancer of Lung, Myeloma
- Being tested
- blood withdrawn
- Keywords
- AA
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute, Lung Neoplasms, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood withdrawnOther
venous blood sampling
| Study group | Role | What they receive |
|---|---|---|
| A: Acute leukemia | Patients that will receive intensive clinical chemotherapy for acute leukemia or high risk myelodysplasia (RAEB2) Blood withdrawn 5-7 x Receives: Other: blood withdrawn | |
| B: Autologous transplantation | Patients that will receive high dose chemotherapy and autologous stem cell rescue for varies hematological malignancies Blood withdrawn 5-7 x Receives: Other: blood withdrawn | |
| C: controls | Healthy controls, found amongst family members of patients of group A and B Blood withdrawn 5-7 x Receives: Other: blood withdrawn | |
| 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 Receives: Other: blood withdrawn | |
| 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 Receives: Other: blood withdrawn | |
| F: controls | Healthy controls, found amongst family members of patients of group D and E Blood withdrawn 5-7 x Receives: Other: blood withdrawn |
What is being measured
The primary outcome is the main question the study is designed to answer.
AA level in leukocytes
change in AA level during chemotherapy
Measured: Baseline to week 4
Secondary outcomes (2)
AA level in plasma
Measured: Baseline, week 1, week 2, week 3, week 4, week 8
AA level in leukocytes
Measured: Baseline to week 1, to week 3, to week 3 and to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study start1 Sep 2016
- Primary completionSep 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia (Both ALL and AML)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerard Bos, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931942
- Sponsor's protocol ID
- NL53414.068.15/METC152025
- Status last verified
- Mar 2023
- First submitted
- 15 Sep 2016
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Changing Over Time of Ascorbic Acid After Chemotherapy
- ClinicalTrials.gov ID
- NCT02931942
- Acronym / sponsor ID
- NL53414.068.15/METC152025
- Conditions
- Leukemia (Both ALL and AML), Cancer of Lung, Myeloma
- Keywords
- AA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A: Acute leukemia | – | Other: blood withdrawnPatients that will receive intensive clinical chemotherapy for acute leukemia or high risk myelodysplasia (RAEB2) Blood withdrawn 5-7 x |
| B: Autologous transplantation | – | Other: blood withdrawnPatients that will receive high dose chemotherapy and autologous stem cell rescue for varies hematological malignancies Blood withdrawn 5-7 x |
| C: controls | – | Other: blood withdrawnHealthy controls, found amongst family members of patients of group A and B Blood withdrawn 5-7 x |
| D: lung cancer | – | Other: blood withdrawnPatients 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 | – | Other: blood withdrawnPatients 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 | – | Other: blood withdrawnHealthy controls, found amongst family members of patients of group D and E Blood withdrawn 5-7 x |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Like explained before, there will be 6 different groups of participants: 1. Patients that will receive intensive clinical chemotherapy for acute leukemia or high risk myelodysplasia (RAEB2) 2. Patients that will receive high dose chemotherapy and autologous stem cell rescue for varies hematological malignancies 3. Patients that will receive relatively mild immunosuppressive chemotherapy for lung cancer, that will mostly be in the outpatient setting 4. Patients that will receive relatively mild immunosuppressive chemotherapy for colon cancer, that will mostly be in the outpatient setting and mostly adjuvant 5. Healthy controls, found amongst family members of patients of group 1 and 2 6. Healthy controls, found amongst family members of patients of group 3 and 4
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood withdrawnvenous blood sampling | Other | A: Acute leukemia, B: Autologous transplantation, C: controls, D: lung cancer, E: colon cancer, F: controls |
Primary outcome
AA level in leukocytes
Time frame: Baseline to week 4
change in AA level during chemotherapy
2 secondary outcomes
AA level in plasma
Time frame: Baseline, week 1, week 2, week 3, week 4, week 8
AA level in leukocytes
Time frame: Baseline to week 1, to week 3, to week 3 and to week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Leukemia (Both ALL and AML)
Recruiting
Efficacy of a Smart Holistic Health Care Platform Intervention on Cancer Children and Parents' Bio-Psycho-Social and Spiritual Health
Leukemia (Both ALL and AML), Brain Tumors
RecruitingObservational study
Symptom Cluster Heterogeneity and Gut Microbiota Mechanisms in Childhood Cancer Survivors
Cancer, Glioma
Not yet recruitingPhase 1
Phase I Clinical Trial of ThINKK Adoptive Immunotherapy After Allogeneic Hematopoietic Transplantation in Children With Leukemia or Neuroblastoma
Leukaemia (Acute Lymphoblastic), Leukaemia (Acute Myeloid)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerard Bos, MD, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia (Both ALL and AML) and Cancer of Lung, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AA level in leukocytes (time frame: Baseline to week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.