Caphosol in Sarcoma Patients With Mucositis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00965172
Recruitment Status : Completed
First Posted : August 25, 2009
Last Update Posted : March 22, 2012
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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).

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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Arm Intervention/treatment
Experimental: Caphosol
Caphosol (calcium phosphate)
Other: Caphosol
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

Primary Outcome Measures :
  1. 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). ]

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with sarcoma which is locally advanced, at high risk for relapse or metastatic for whom treatment with high dose doxorubicin (75-90 mg/m^2) with ifosfamide (AI) or cisplatin (AP) is indicated.
  2. Must be >16 and < 65 years of age.
  3. Females of childbearing potential (defined as not post-menopausal for 12 months, or no previous surgical sterilization) must have a negative blood pregnancy test.
  4. Male and Females of child bearing potential must use acceptable methods of birth control which include oral contraceptives, spermicide with either a condom, diaphragm or cervical cap, us of a intrauterine device (IUD) or abstinence.
  5. Adequate hematologic (ANC > 1500/mm^3, platelet count > 150,000/mm^3), renal (serum creatinine < 1.5mg/dL), hepatic (serum bilirubin count < 1.5 x normal and SGPT <3 x normal) functions.
  6. Karnofsky Performance Status >/= 80%
  7. Signed informed consent form.

Exclusion Criteria:

  1. Pregnant or lactating women.
  2. Patients with any co-morbid condition which renders patients at high risk of treatment complication.
  3. Patient has uncontrolled angina, congestive heart failure (New York Heart Association > class II or known ejection fraction < 40%), uncontrolled cardiac arrhythmia or hypertension, acute myocardial infarction within 3 months
  4. Patient has an active seizure disorder. (Patients with a previous history of seizure disorders will be eligible for the study, if they have had no evidence of seizure activity, and they have been free of antiseizure medication for the previous 5 years.)
  5. Prior surgery or radiotherapy (RT) within 2 weeks of study entry.
  6. Psychological, social, familial, or geographical reasons that would prevent scheduled visits and follow-up.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00965172

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Study Chair: Saroj Vadhan-Raj, MD UT MD Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00965172     History of Changes
Other Study ID Numbers: 2008-0276
First Posted: August 25, 2009    Key Record Dates
Last Update Posted: March 22, 2012
Last Verified: March 2012

Keywords provided by M.D. Anderson Cancer Center:
Calcium phosphate
Sodium Bicarbonate
Baking Soda Solution
Multi-cycle chemotherapy

Additional relevant MeSH terms:
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs