Status:
COMPLETED
Caphosol in Sarcoma Patients With Mucositis
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Sarcoma
Oral Mucositis
Eligibility:
All Genders
16-65 years
Phase:
PHASE2
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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.
- Must be \>16 and \< 65 years of age.
- Females of childbearing potential (defined as not post-menopausal for 12 months, or no previous surgical sterilization) must have a negative blood pregnancy test.
- 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.
- 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.
- Karnofsky Performance Status \>/= 80%
- Signed informed consent form.
Exclusion
- Pregnant or lactating women.
- Patients with any co-morbid condition which renders patients at high risk of treatment complication.
- 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
- 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.)
- Prior surgery or radiotherapy (RT) within 2 weeks of study entry.
- Psychological, social, familial, or geographical reasons that would prevent scheduled visits and follow-up.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00965172
Start Date
April 1 2010
End Date
February 1 2012
Last Update
March 22 2012
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030