Caphosol in Sarcoma Patients With Mucositis
|ClinicalTrials.gov Identifier: NCT00965172|
Recruitment Status : Completed
First Posted : August 25, 2009
Last Update Posted : March 22, 2012
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).
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma Oral Mucositis||Other: Caphosol Other: Baking Soda||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2010|
|Primary Completion Date :||February 2012|
|Study Completion Date :||February 2012|
U.S. FDA Resources
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
- 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). ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00965172
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Saroj Vadhan-Raj, MD||UT MD Anderson Cancer Center|