Changing Over Time of Ascorbic Acid After Chemotherapy

Myeloma Clinical Trial

Official title:

The Changing Over Time of Ascorbic Acid After Chemotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02931942
• Other study ID #: NL53414.068.15/METC152025
• Status: Active, not recruiting
• Start date: September 1, 2016
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Lung
• Leukemia (Both ALL and AML)
• Lung Neoplasms
• Myeloma

Intervention

Other:
• blood withdrawn
venous blood sampling

Locations

Country	Name	City	State
Netherlands	MUMC+	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AA level in leukocytes	change in AA level during chemotherapy	Baseline to week 4
Secondary	AA level in plasma		Baseline, week 1, week 2, week 3, week 4, week 8
Secondary	AA level in leukocytes		Baseline to week 1, to week 3, to week 3 and to week 8