Supersaturated Calcium Phosphate Oral Rinse (Caphosol®) For the Prevention of Oral Mucositis in Children Undergoing Chemotherapeutic Treatments

• Status: Completed
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tampere University Hospital
• Collaborators: Kuopio University Hospital; Turku University Hospital

Criteria

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).