Clinical trial · Interventional
Comparative Trial of Cryotherapy Versus Caphosol Versus Saline Solution Mouth Washes for the Prevention of Oral Mucositis in Patients With Multiple Myeloma Undergoing Hematopoietic Stem Cell Transplantation
A Prospective, Randomized, Comparative Trial of Cryotherapy Versus Caphosol Versus Saline Solution Mouth Washes for the Prevention of Oral Mucositis in Patients With Multiple Myeloma Undergoing Hematopoietic Stem Cell Transplantation.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Chemotherapy-induced oral mucositis is the inflammation of the oral mucous membranes, which are tissues that line the mouth. Oral mucositis is caused when chemotherapy attacks and kills the rapidly-dividing cells in the oral mucous membranes. This condition feels like sunburn (or heartburn) on the mucous tissues, and often leads to sores in the mouth or on the tongue. This can cause discomfort, pain, difficulties in eating, and a longer hospital stay. Several therapies appear to either prevent or reduce the severity of mouth ulcers caused by chemotherapy for multiple myeloma. Different strategies are used to try and prevent this condition; a small number of trials found that some of these strategies may be effective. None of the trials had compared head to head the use of saline solution (our standard of care), cryotherapy (ice chips) and Caphosol in patients receiving high-dose melphalan. The goal of this research study to evaluate the effectiveness of saline solution, cryotherapy, Caphosol for the prevention of oral mucositis in patients with multiple myeloma receiving high-dose chemotherapy followed by autologous hematopoietic stem cell transplantation. The researchers hope to learn if there are any differences among saline solution, cryotherapy and Caphosol mouth rinse for the prevention of oral mucositis.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mucositis | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 0.9% Sodium Chloride irrigation solution | Drug | — | UNRESOLVED |
| Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse | Device | — | UNRESOLVED |
| Cryotherapy (ice chips) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- 0.9% Sodium Chloride irrigation solution
- description
- Standard of care for prevention and management of oral mucositis (0.9% Sodium Chloride irrigation solution): Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study.
- interventionNames
- Drug: 0.9% Sodium Chloride irrigation solution
- type
- ACTIVE_COMPARATOR
- label
- Cryotherapy (ice chips)
- description
- Patients randomized to this group, on day -2 and -1, will be instructed to place approximately 1 ounce of crushed ice in their mouths 15 minutes prior to the initiation of melphalan infusion. The ice will be allowed to melt and should be replenish as soon as it had completely melted. Patients will be instructed to continue this procedure during the melphalan infusion and for 90 minutes after the end of the infusion. After patients are done with the cryotherapy they will follow the standard of care for prevention and management of oral mucositis until the end of the study.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patients must meet the following criteria to participate in this study: * Age 18 years or older * Patients with diagnosis of MM schedule to receive high-dose melphalan, as a single agent ,for conditioning regimen * Signed Informed Consent Form Exclusion Criteria: Patients will be excluded from the study for any of the following reasons: * Patients who have taken palifermin (Kepivance) in the past 90 days * Patients who have taken any investigational drug in the past 60 days * Patient who have received radiation therapy in the past 60 days * Serum creatinine greater than 2 mg/dL * Patients with mucositis at the time of randomization * Patients with altered mental status precluding understanding of the informed consent process an/or completion of the necessary assessments
References
Publications (0)
Data not yet available