drugset / Trial / NCT02807337
Supersaturated Calcium Phosphate Oral Rinse (Caphosol®) For the Prevention of Oral Mucositis in Children Undergoing Chemotherapeutic Treatments
Phase 2
Completed
47 enrolled
Tampere University Hospital
Kuopio University Hospital · collabTurku University Hospital · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
Prospective double-blinded randomized clinical study. Aim of the study is to compare the effectiveness of Caphosol mouth rinses in prevention of oral mucositis as compared to 0.9% NaCl rinses. Patients will be randomized to receive either Caphosol or 0.9% NaCl rinses four times a day for seven days from the beginning of chemotherapeutic regimen. The same patient will be given the opposite rinse during the next chemotherapeutic regimen, so everyone will get both mouth rinses once during the trial.
Timeline
- Start
- 2016-08-01
- Primary completion
- 2019-12-31
- Completion
- 2019-12-31
Publications
- Immonen E, Paulamaki L, Piippo H, Nikkila A, Aine L, Peltomaki T, Lohi O, Parikka M. Oral microbiome diversity and composition before and after chemotherapy treatment in pediatric oncology patients. BMC Oral Health. 2025 Jul 2;25(1):981. doi: 10.1186/s12903-025-06405-4.
- Immonen E, Aine L, Nikkila A, Parikka M, Gronroos M, Vepsalainen K, Palmu S, Helminen M, Peltomaki T, Lohi O. Randomized controlled and double-blinded study of Caphosol versus saline oral rinses in pediatric patients with cancer. Pediatr Blood Cancer. 2020 Oct;67(10):e28520. doi: 10.1002/pbc.28520. Epub 2020 Jul 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Caphosol | Other / unclassified | — | Topical |