Changing Over Time of Ascorbic Acid After Chemotherapy

NCT ID: NCT02931942

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2023-12-31

Brief 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. 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.

Conditions

Leukemia (Both ALL and AML); Cancer of Lung; Myeloma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

A: Acute leukemia

Patients that will receive intensive clinical chemotherapy for acute leukemia or high risk myelodysplasia (RAEB2) Blood withdrawn 5-7 x

blood withdrawn

Intervention Type: OTHER

venous blood sampling

B: Autologous transplantation

Patients that will receive high dose chemotherapy and autologous stem cell rescue for varies hematological malignancies Blood withdrawn 5-7 x

blood withdrawn

Intervention Type: OTHER

venous blood sampling

C: controls

Healthy controls, found amongst family members of patients of group A and B Blood withdrawn 5-7 x

blood withdrawn

Intervention Type: OTHER

venous blood sampling

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

blood withdrawn

Intervention Type: OTHER

venous blood sampling

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

blood withdrawn

Intervention Type: OTHER

venous blood sampling

F: controls

Healthy controls, found amongst family members of patients of group D and E Blood withdrawn 5-7 x

blood withdrawn

Intervention Type: OTHER

venous blood sampling

Interventions

blood withdrawn

venous blood sampling

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerard Bos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

MUMC+

Maastricht, Limburg, Netherlands

Countries

Netherlands

Other Identifiers

NL53414.068.15/METC152025

Identifier Type: -

Identifier Source: org_study_id