Caphosol in Sarcoma Patients With Mucositis
Condition: Sarcoma; Oral Mucositis
MeSH terms: Sarcoma; Mucositis; Stomatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this clinical research study is to find out if Caphosol® (calcium phosphate)
      mouthwash is more effective than a baking soda solution at preventing and treating mucositis,
      in patients with sarcoma who are to be treated with chemotherapy. The safety of this drug
      will also be studied. Researchers also want to learn about the way calcium phosphate may
      affect mucous membranes.

      The goal of this clinical research study is to see if Caphosol® (calcium phosphate) mouthwash
      is better than baking soda solution in patients with sarcoma who are to be treated with
      chemotherapy . Caphosol will also be studied to see if it lessens the incidence and severity
      of oral mucositis (painful sores in the mouth).
    

Detailed description: 
      Chemotherapy and radiation therapy can hurt normal cells in the gastrointestinal tract (which
      includes the mouth and intestines). When this happens, it can cause mucositis (inflammation
      of the lining of the mouth, throat, and intestines). Researchers want to compare the effects
      of calcium phosphate and baking soda on patients who are at risk for mucositis.

      The Study Drugs:

      Caphosol (calcium phosphate) is a saliva-like liquid that is designed to replace the chemical
      and pH (acid) balance in the mouth. It is used as a mouth rinse to moisten, lubricate, and
      clean the mouth, including the lining of the mouth, tongue, and throat. It is also used to
      loosen thick mucous and help prevent the mucous membranes from sticking together.

      Baking soda is used as the standard of care for preventing and treating mucositis.

      Study Groups:

      If you are found to be eligible to take part in this study, you will be randomly assigned (as
      in the flip of a coin) to receive either calcium phosphate mouth rinse or the baking soda
      mouth rinse during the study. There is an equal chance of being assigned to either group.

      You will use the mouth rinse 5 times every day. The study staff will explain how to mix and
      rinse with it.

      Calcium phosphate should be stored at room temperature and should not be refrigerated. If you
      are on a low sodium diet, you should check with your doctor before using calcium phosphate.

      Baseline Tests:

      The following tests and procedures will be performed before you receive your first dose of
      chemotherapy:

        -  Blood (about 3 teaspoons) will be drawn for routine tests.

        -  The mucous membranes in your mouth will be checked.

        -  You will be asked to complete a questionnaire (about 15 minutes) on how you feel.

        -  You will be given a diary before you start each cycle to record if you have any mouth
           pain.

      Study Tests:

      You will need to come to MD Anderson on around Days 10, 12, and 14 (depending on the status
      of the mucositis) of each chemotherapy cycle. During these clinic visits, the following tests
      and procedures may be performed:

        -  You will have a physical exam, including measurement of your vital signs and weight.

        -  Blood (about 3 teaspoons) will be drawn for routine tests.

        -  The mucous membranes in your mouth will be checked. Also, you may have your mouth and
           throat photographed.

        -  You will be asked to complete the questionnaire on how you feel.

        -  When possible, the optical imaging procedures will also be performed on these days.

      Length of Study and Reasons for Leaving the Study Early:

      You will take part in this study for up to 18 weeks (4 to 5 months). You will be taken off
      study if you experience intolerable side effects.

      End of Study Visit:

      You will also have an end of study visit after you complete 6 cycles of study drug, if you
      are taken off study for any reason, or if you choose to leave the study. During this visit,
      the following tests and procedures will be performed:

        -  You will have a physical exam, including measurement of your vital signs and weight.

        -  Blood (about 3 teaspoons) will be drawn for routine tests.

        -  The mucous membranes in your mouth will be checked.

        -  You will be asked to complete the questionnaire on how you feel.

        -  You will receive a phone call from the nurse after you last dose of study drug to follow
           up on any side effects.

      This is an investigational study. Caphosol (calcium phosphate) is FDA approved and
      commercially available for use in preventing and treating mucositis, and for relief of dry
      mouth during high dose chemotherapy or radiation treatment.

      Up to 30 patients will take part in this study. All will be enrolled at M. D Anderson.
    

Intervention name(s): Caphosol; Baking Soda
Intervention type(s): Other; Other
Intervention description(s): Oral rinse of calcium phosphate solution five times daily beginning on day one of chemotherapy.; Oral rinse of baking soda solution as per standard of care five times daily beginning on day one of chemotherapy.
Other intervention name(s): calcium phosphate; Sodium Bicarbonate
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer; Mucositis; Chemotherapy; Caphosol; Calcium phosphate; Sodium Bicarbonate; Baking Soda Solution; Multi-cycle chemotherapy