Effect of Vitamin C in Autologous Stem Cell Transplantations

Lymphoma Clinical Trial

— VICAST  

Official title:

Randomized Controlled Trial on the Effect of Vitamin C Supplementation in Autologous Stem Cell Transplantations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03964688
• Other study ID #: NL68010.068.18
• Secondary ID: 2018-004135-77
• Status: Completed
• Phase: Phase 2
• Start date: December 10, 2019
• Est. completion date: March 1, 2022

Study information

• Verified date: April 2022
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the study the investigators will randomize patients that receive an autologous stem cell transplantation for myeloma or lymphoma for treatment with vitamin C or placebo during 6 weeks. Primary endpoint will be immune recovery.

Description:

Rationale: Recent studies showed that ascorbic acid (AA) stimulates proliferation and maturation of T lymphocytes and natural killer (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 followed by autologous stem cell transplantation for hematological malignancies. AA supplementation could be beneficial to the recovery of the immune system in these patients.

Objective: The aim of this study is to examine the effect of vitamin C supplementation on immune recovery in patients with autologous stem cell transplantation. The aim of the run-in phase of the study is to examine the effect of intravenous vitamin C supplementation on plasma concentrations of vitamin C in patients with autologous stem cell transplantation at day 14 in order to be sure that in the intervention study accurate AA plasma levels will be present.

Study design: run-in phase, followed by randomized controlled trial Study population: All participants will be adults (minimally 18 years old) that are planed to receive an autologous stem cell transplantation for multiple myeloma or lymphoma and are recruited at the MUMC+. In total there will be 3 expected (run-in phase) + 44 (randomized controlled trial) participants.

Main study parameters/endpoints: Primary endpoints will be AA plasma level on day 14 (run-in phase) and the day of neutrophil recovery after stem cell transplantation (randomized-controlled phase). Secondary endpoints will be AA leukocyte levels, infection rate, duration of hospital stay, side effects of chemotherapy, overall survival, coagulation parameters, platelet reactivity, fibrinolysis and quality of life.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

AA supplementation could be beneficial for the immune recovery in the participants of this study. The risks associated with participation in this study are low. Vitamin C supplementation is safe and hardly has any documented side effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older

• written informed consent

• diagnosis of malignant lymphoma or multiple myeloma

• require chemotherapy plus autologous stem cell transplantation as standard of care for the disease at that stage

• central venous catheter in place or planned

Exclusion Criteria:

• inability to understand the nature and extent of the trial and the procedures required

• history of kidney stones

• kidney failure requiring dialysis or eGFR <30 mL/min. (CDK-EPI formula)

• history of G6PD deficiency

• life expectancy < 1 month

• use of immunosuppressive medication other than chemotherapy and corticosteroids

Related Conditions & MeSH terms

• Lymphoma
• Multiple Myeloma
• Myeloma Multiple
• Neoplasms, Plasma Cell

Intervention

Drug:
• Vitamin C
vitamin C intravenous during hospitalization, after oral, total 6 weeks.
• Placebos
placebo intravenous during hospitalization, after oral, total 6 weeks

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	immune recovery	the day of repopulation (return of neutrophil to at least 0.5 × 109/l) after autologous stem cell transplantation.	day 14-28
Secondary	AA plasma levels	AA plasma levels	day 14
Secondary	AA leukocyte levels	AA leukocyte levels	day 14
Secondary	Incidence of infections/ neutropenic fever	fever and infections during hospitalization	day 1-28
Secondary	Days of hospitalization	number of days patients are admitted in our hospital	dag 1-28
Secondary	Days with fever (= 38.5° C)	Amount of days admitted patients have a fever	day 1-28
Secondary	Incidence of bloodstream infections	number of bloodstream infections of admitted patients	day1-28
Secondary	Quality of life according to the EORTC QLQ-C30	quality of live questionaire	Day 0, day 14, day 42
Secondary	Overall survival (3 months)	overall survival at 3 months	3 months
Secondary	Relapse rates (3 months)	relapse rate at 3 months	3 months
Secondary	Use of systemic antimicrobial agents (incidence and duration)	use of antibiotics during hospitalization	dau 1-28
Secondary	platelet reactivity	platelet reactivity tests	day 10
Secondary	ROS production	ROS production platelets	day 10
Secondary	platelet mitochondrial dysfunction	platelet mitochondrial function test	day 10
Secondary	number and severity of bleeding episodes during admission	number and severity of bleeding episodes during admission	day 1-28