Supersaturated Calcium Phosphate Oral Rinse (Caphosol®) For the Prevention of Oral Mucositis in Children Undergoing Chemotherapeutic Treatments
Condition: Cancer
MeSH terms: Mucositis; Stomatitis
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      The study will be a double-blinded study so that the researchers or research nurses and the
      patients/parents are unaware of the solution used (Caphosol vs 0.9% NaCl). They both taste
      very similar and are packaged to ampules similar to each other. Since Caphosol consists of
      two solutions (A and B) which are mixed immediately before use, the investigators will apply
      the same procedure also in case of 0.9% NaCl solution (two vials of 0.9% NaCl will be mixed)
      to maintain blinding. Caphosol and 0.9% NaCl rinses will be relabeled to maintain blinding.
      Every patient will participate two times in the study. The treatment group allocation is
      based on randomization and will be performed once before participation for the first time.
      During another chemotherapeutic regimen, the same patient will automatically use another
      mouth rinse (Group 1 => Group 2 and Group 2 => Group 1). This dependence-effect caused by
      observations gathered from same patients will be taken into account when analysing the data.
      Blinding will be maintained throughout the study.

      The investigators estimate that occurrence of oral mucositis as a side effect of
      chemotherapeutic treatment differs by 3-fold in different study arms (10% in Caphosol group,
      and 30% in 0.9% NaCl group). Power calculations using power of 0.8 and p-value of 0.05
      indicate that the 70 children are needed to be recruited into each arm, i.e. two repeated
      measurements from 70 children are needed to have adequate statistical power. A drop-out of
      approximately 3-5% of patients has been taken into account and therefore the investigators
      plan to recruit 75 patients. Randomization will be performed using freely available and
      web-based MINIM-randomization software.

      The data analysis will be performed on intention-to-treat principle. Mixed-effect regression
      methods will be used due to repeated observation within study subjects.

      Specific methods used for this study:

        -  Oral mucositis will be assessed daily for all patients at the oncology ward and at home
           by use of the Children International Mucositis Evaluation Scale and World Health
           Organization oral mucositis scale.

        -  In the beginning of study, initial clinical evaluation will be performed by a pediatric
           dentist. During the stay at hospital, parents/patients (or nurses) will fill in the oral
           mucositis scales. At home, the patients/parents fill the scales. Scales will be filled
           in once a day for 14 consecutive days. Caphosol / 0.9% NaCl rinse treatment will last
           for only 7 consecutive days.

        -  The available medical and dental records will be audited for the frequency of oral
           mucositis.

        -  Oral samples will be collected by a pediatric dentist, and bacterial analyses will be
           performed by microbiologist at University of Tampere.

        -  Laboratory values and pain medications will be retrieved from electronic patient files
           (MIRANDA/Fimlab).

        -  Blood tests will be collected for possible later use in genetic studies.
    

Intervention name(s): Caphosol; 0,9% NaCl
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Oral mucositis