N/A
Completed N=117
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 NCT01066624 ↗Enrolled (actual)
117
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcomePrimary: Incidence of Oral Mucositis — 66; 10; 64 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Oral Mucositis |
66; 10; 64 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01066624). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.