Clinical trial · Interventional
Supersaturated Calcium Phosphate Oral Rinse (Caphosol®) For the Prevention of Oral Mucositis in Children Undergoing Chemotherapeutic Treatments
NCT02807337CI-TRIAL-00043531completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 0,9% NaCl | Drug | — | UNRESOLVED |
| Caphosol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Caphosol rinse group
- description
- Caphosol consists of two solutions (A and B) which are mixed immediately before use. Caphosol mouth rinse will begin concomitantly (the same day) with the beginning of chemotherapeutic drugs. It will be continued for seven consecutive days.
- interventionNames
- Drug: Caphosol
- type
- ACTIVE_COMPARATOR
- label
- 0,9% NaCl group.
- description
- 0,9% NaCl consists of two solutions (A and B). Two vials of 0.9% NaCl will be mixed to maintain blinding. The study mouth rinse will begin concomitantly (the same day) with the beginning of chemotherapeutic drugs. It will be continued for seven consecutive days.
- interventionNames
- Drug: 0,9% NaCl
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria:
1. Pediatric cancer patients aged 2 - 17.99 years old
2. Patients diagnosed with solid or hematological malignancy and receiving chemotherapeutic drugs.
3. Use of the following mucosa-breaking chemotherapeutic drugs: high-dose methotrexate, any anthracycline (doxorubicin, daunorubicin, idarubicin, mitoxantrone), and cisplatin.
4. Protocol must include potential mucosa-breaking chemotherapeutic cycles at least twice in the protocol.
Exclusion Criteria:
1. Patients younger than 2 years old or older than 18 years.
2. Patients who have mucositis at the start of chemotherapeutic regimen.
3. Less than three weeks from previous treatment ("washout" period).
4. High-dose chemotherapy with stem cell transplantation patients.
5. Induction treatment (leukemia).References
Publications (2)
- DERIVEDImmonen 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. PMID 40604730
- DERIVEDImmonen 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. PMID 32725875