Effect of Vitamin C in Autologous Stem Cell Transplantations (VICAST)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03964688|
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : May 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Myeloma Multiple Lymphoma||Drug: Vitamin C Drug: Placebos||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||double blind placebo-controlled randomized trial|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomized Controlled Trial on the Effect of Vitamin C Supplementation in Autologous Stem Cell Transplantations|
|Estimated Study Start Date :||May 27, 2019|
|Estimated Primary Completion Date :||March 1, 2021|
|Estimated Study Completion Date :||September 1, 2021|
Experimental: Vitamin C
vitamin C intravenous during hospitalization, followed with vitamin C oral
Drug: Vitamin C
vitamin C intravenous during hospitalization, after oral, total 6 weeks.
Other Name: ascorbic acid
placebo intravenous during hospitalization, followed with placebo oral
placebo intravenous during hospitalization, after oral, total 6 weeks
Other Name: placebo
- immune recovery [ Time Frame: day 14-28 ]the day of repopulation (return of neutrophil to at least 0.5 × 109/l) after autologous stem cell transplantation.
- AA plasma levels [ Time Frame: day 14 ]AA plasma levels
- AA leukocyte levels [ Time Frame: day 14 ]AA leukocyte levels
- Incidence of infections/ neutropenic fever [ Time Frame: day 1-28 ]fever and infections during hospitalization
- Days of hospitalization [ Time Frame: dag 1-28 ]number of days patients are admitted in our hospital
- Days with fever (≥ 38.5° C) [ Time Frame: day 1-28 ]Amount of days admitted patients have a fever
- Incidence of bloodstream infections [ Time Frame: day1-28 ]number of bloodstream infections of admitted patients
- Quality of life according to the EORTC QLQ-C30 [ Time Frame: Day 0, day 14, day 42 ]quality of live questionaire
- Overall survival (3 months) [ Time Frame: 3 months ]overall survival at 3 months
- Relapse rates (3 months) [ Time Frame: 3 months ]relapse rate at 3 months
- Use of systemic antimicrobial agents (incidence and duration) [ Time Frame: dau 1-28 ]use of antibiotics during hospitalization
- platelet reactivity [ Time Frame: day 10 ]platelet reactivity tests
- ROS production [ Time Frame: day 10 ]ROS production platelets
- platelet mitochondrial dysfunction [ Time Frame: day 10 ]platelet mitochondrial function test
- number and severity of bleeding episodes during admission [ Time Frame: day 1-28 ]number and severity of bleeding episodes during admission
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964688
|Contact: Gwendolyn van Gorkomfirstname.lastname@example.org|
|Contact: Gerard Bosemail@example.com|
|Principal Investigator:||Gerard Bos||Maastricht University Medical Center|