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Effect of Vitamin C in Autologous Stem Cell Transplantations (VICAST)
| 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 |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | double blind placebo-controlled randomized trial |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Arm | Intervention/treatment |
|---|---|
|
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
|
|
Experimental: Placebo
placebo intravenous during hospitalization, followed with placebo oral
|
Drug: Placebos
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
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
| Contact: Gwendolyn van Gorkom | 0031433877026 | gwendolyn.van.gorkom@mumc.nl | |
| Contact: Gerard Bos | 0031433877026 | gerard.bos@mumc.nl |
| Netherlands | |
| MUMC+ | Recruiting |
| Maastricht, Limburg, Netherlands | |
| Contact: Gwendolyn van Gorkom 0031433877026 gwendolyn.van.gorkom@mumc.nl | |
| Contact: Gerard Bos 0031433877026 gerard.bos@mumc.nl | |
| Principal Investigator: | Gerard Bos | Maastricht University Medical Center |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 9, 2019 | ||||||||
| First Posted Date ICMJE | May 28, 2019 | ||||||||
| Last Update Posted Date | May 28, 2019 | ||||||||
| Estimated Study Start Date ICMJE | May 27, 2019 | ||||||||
| Estimated Primary Completion Date | March 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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.
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effect of Vitamin C in Autologous Stem Cell Transplantations | ||||||||
| Official Title ICMJE | Randomized Controlled Trial on the Effect of Vitamin C Supplementation in Autologous Stem Cell Transplantations | ||||||||
| Brief 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. | ||||||||
| Detailed 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: double blind placebo-controlled randomized trial Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
47 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | September 1, 2021 | ||||||||
| Estimated Primary Completion Date | March 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Netherlands | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03964688 | ||||||||
| Other Study ID Numbers ICMJE | NL68010.068.18 2018-004135-77 ( EudraCT Number ) |
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| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Maastricht University Medical Center | ||||||||
| Study Sponsor ICMJE | Maastricht University Medical Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Maastricht University Medical Center | ||||||||
| Verification Date | May 2019 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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