Caphosol in Sarcoma Patients With Mucositis
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00965172
First received: August 21, 2009
Last updated: March 20, 2012
Last verified: March 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Sarcoma Oral Mucositis |
Other: Caphosol Other: Baking Soda |
Phase 2 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- 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 ]
| Enrollment: | 30 |
| Study Start Date: | April 2010 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 16 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00965172
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Study Chair: | Saroj Vadhan-Raj, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00965172 History of Changes |
| Other Study ID Numbers: | 2008-0276 |
| Study First Received: | August 21, 2009 |
| Last Updated: | March 20, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Cancer Mucositis Chemotherapy Caphosol |
Calcium phosphate Sodium Bicarbonate Baking Soda Solution Multi-cycle chemotherapy |
Additional relevant MeSH terms:
|
Stomatitis Mucositis Sarcoma Mouth Diseases Stomatognathic Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on May 22, 2013