Changing Over Time of Ascorbic Acid After Chemotherapy

NCT02931942 | Unknown

• 1 other identifier: NL53414.068.15/METC152025
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

AA

Outcome Measures

Primary Outcomes (1)

• AA level in leukocytes

  change in AA level during chemotherapy

  Baseline to week 4

Secondary Outcomes (2)

• 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

Study Arms (6)

A: Acute leukemia

Patients that will receive intensive clinical chemotherapy for acute leukemia or high risk myelodysplasia (RAEB2) Blood withdrawn 5-7 x

Other: blood withdrawn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

Other: blood withdrawn

C: controls

Healthy controls, found amongst family members of patients of group A and B Blood withdrawn 5-7 x

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

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

Other: blood withdrawn

F: controls

Healthy controls, found amongst family members of patients of group D and E Blood withdrawn 5-7 x

Other: blood withdrawn

Interventions

blood withdrawn OTHER

venous blood sampling

A: Acute leukemia; B: Autologous transplantation; C: controls; D: lung cancer; E: colon cancer; F: controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

MUMC+

Maastricht, Limburg, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

peripheral blood on AA level and blood count

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Acute; Lung Neoplasms; Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Gerard Bos, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2016
• First Posted: October 13, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)