Caphosol in Sarcoma Patients With Mucositis
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study to Evaluate the Preliminary Efficacy Assessment of Caphosol in Patients With Sarcoma Receiving Multicycle Chemotherapy With Doxorubicin and Ifosfamide or Cisplatin|
- Incidence/Severity of Oral Mucositis WHO Grades 1, 2, 3, and 4 [ Time Frame: Incidence of mucositis (all grades) within 6 cycles of treatment (estimate 18 weeks, 4 to 5 months). ] [ Designated as safety issue: No ]
|Study Start Date:||April 2010|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Caphosol (calcium phosphate)
Oral rinse of calcium phosphate solution five times daily beginning on day one of chemotherapy.
Other Name: calcium phosphate
Active Comparator: Baking Soda
Control Group (standard of care)
Other: Baking Soda
Oral rinse of baking soda solution as per standard of care five times daily beginning on day one of chemotherapy.
Other Name: Sodium Bicarbonate
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|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Saroj Vadhan-Raj, MD||UT MD Anderson Cancer Center|