Caphosol in Sarcoma Patients With Mucositis

This study has been completed.
Sponsor:
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
  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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014