Caphosol Study: Prevention of Oral Mucositis in Children, Adolescents and Young Adults Receiving Chemotherapy
Condition: Oral Mucositis
MeSH terms: Mucositis; Stomatitis
Intervention: Caphosol; Biotene
Intervention description: Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day as follows:
Each dose consists of two 15 mL syringes, to be mixed at time of administration. Caphosol must be used within 15 minutes of mixing.
o Participants may increase the use to 6 times per day if you have symptoms of mucositis.
Using one of the syringes, rinse and gargle (if patient is able) for one minute and then spit. Repeat using the remaining syringe.
For younger patients (less than or equal to 6 years of age), volume may be reduced to two syringes containing 5-10 mL each.
For patients unable to successfully rinse and spit, caregivers may paint their mouth (using medical sponge swabs) with the solution two times. Repeat using the second syringe.
Patients are to avoid other oral medications, other mouth cares and food or drink for 15 minutes after using Caphosol.
Patients may use Biotene (5-10 mL) to swish and spit after the 15 minutes has passed; • Use 5 to 10 mL of Biotene to swish and spit
o For patients unable to successfully rinse and spit, caregivers may paint their mouth (using medical sponge swabs) with the solution two times. Prior to swabbing the patient's mouth, pour Biotene into a cup and using the medical sponge, soak up the solution and use the swab to coat the inside of the patient's mouth. Repeat with a second swab.
Intervention MeSH terms: Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Maximum age: 25 Years
Healthy volunteers: No
Keywords: Oral Mucositis; Cancer; Chemotherapy

Summary:

      The purpose of this study is to determine if the administration of Caphosol rinse, at the
      start of chemotherapy, will prevent the development of mucositis (greater than or equal to
      grade 2 in children, adolescents and young adults. This is a randomized, controlled trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Oncology patients, at initiation of their oncology therapy, who are at risk of
             developing oral mucositis during their scheduled cancer therapy, defined by meeting
             one or more of the following criteria:

          -  Patients receiving one or more of the following chemotherapy agents:

               -  Actinomycin D

               -  Carboplatin

               -  Cisplatin

               -  Cytarabine at doses > 1 gram/m2

               -  Daunorubicin

               -  Doxorubicin

               -  Methotrexate at doses > 1 gram/m2

               -  Mitoxantrone

          -  Age 0 to 25 years

          -  Voluntary written consent before performance of any study-related procedure not part
             of normal medical care, with the understanding that consent may be withdrawn by the
             subject at any time without prejudice to future medical care

        Exclusion Criteria:

          -  Patients receiving glutamine treatment for oral mucositis.

          -  Patients undergoing autologous or allogeneic hematopoietic cell transplantation are
             excluded from this study.

          -  Patients receiving concurrent Head & Neck radiation therapy or within 6 weeks of
             completion of radiation therapy.

          -  Pregnant or lactating patients. The agent used in this study is not known to be
             teratogenic to a fetus, but has not been studies, and there is no information on the
             excretion of the agent into breast milk. All females of childbearing potential must
             have a blood test or urine study within 2 weeks prior to registration to rule out
             pregnancy.

          -  Known allergy to Caphosol