Clinical trial · Interventional
Caphosol in Sarcoma Patients With Mucositis
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Mucositis | — | UNRESOLVED | — |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Baking Soda | Other | — | UNRESOLVED |
| Caphosol | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Caphosol
- description
- Caphosol (calcium phosphate)
- interventionNames
- Other: Caphosol
- type
- ACTIVE_COMPARATOR
- label
- Baking Soda
- description
- Control Group (standard of care)
- interventionNames
- Other: Baking Soda
Primary outcomes (1)
- measure
- Incidence/Severity of Oral Mucositis WHO Grades 1, 2, 3, and 4
- timeFrame
- Incidence of mucositis (all grades) within 6 cycles of treatment (estimate 18 weeks, 4 to 5 months).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available