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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004135-77 | EudraCT Number |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin C | Experimental | vitamin C intravenous during hospitalization, followed with vitamin C oral |
|
| Placebo | Experimental | placebo intravenous during hospitalization, followed with placebo oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin C | Drug | vitamin C intravenous during hospitalization, after oral, total 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| immune recovery | the day of repopulation (return of neutrophil to at least 0.5 × 109/l) after autologous stem cell transplantation. | day 14-28 |
| Measure | Description | Time Frame |
|---|---|---|
| AA plasma levels | AA plasma levels | day 14 |
| AA leukocyte levels | AA leukocyte levels | day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerard Bos | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MUMC+ | Maastricht | Limburg | Netherlands |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 7, 2022 | |
| Reset | Oct 6, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 7, 2022 | Oct 6, 2023 |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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double blind placebo-controlled randomized trial
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| Placebos | Drug | placebo intravenous during hospitalization, after oral, total 6 weeks |
|
|
| Incidence of infections/ neutropenic fever | fever and infections during hospitalization | day 1-28 |
| Days of hospitalization | number of days patients are admitted in our hospital | dag 1-28 |
| Days with fever (≥ 38.5° C) | Amount of days admitted patients have a fever | day 1-28 |
| Incidence of bloodstream infections | number of bloodstream infections of admitted patients | day1-28 |
| Quality of life according to the EORTC QLQ-C30 | quality of live questionaire | Day 0, day 14, day 42 |
| Overall survival (3 months) | overall survival at 3 months | 3 months |
| Relapse rates (3 months) | relapse rate at 3 months | 3 months |
| Use of systemic antimicrobial agents (incidence and duration) | use of antibiotics during hospitalization | dau 1-28 |
| platelet reactivity | platelet reactivity tests | day 10 |
| ROS production | ROS production platelets | day 10 |
| platelet mitochondrial dysfunction | platelet mitochondrial function test | day 10 |
| number and severity of bleeding episodes during admission | number and severity of bleeding episodes during admission | day 1-28 |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008206 | Lymphatic Diseases |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |