NCT00965172

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

March 22, 2012

Status Verified

March 1, 2012

Enrollment Period

1.8 years

First QC Date

August 21, 2009

Last Update Submit

March 20, 2012

Conditions

SarcomaOral Mucositis

Keywords

CancerMucositisChemotherapyCaphosolCalcium phosphateSodium BicarbonateBaking Soda SolutionMulti-cycle chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Incidence/Severity of Oral Mucositis WHO Grades 1, 2, 3, and 4

    Incidence of mucositis (all grades) within 6 cycles of treatment (estimate 18 weeks, 4 to 5 months).

Study Arms (2)

Caphosol

EXPERIMENTAL

Caphosol (calcium phosphate)

Other: Caphosol

Baking Soda

ACTIVE COMPARATOR

Control Group (standard of care)

Other: Baking Soda

Interventions

CaphosolOTHER

Oral rinse of calcium phosphate solution five times daily beginning on day one of chemotherapy.

Also known as: calcium phosphate
Caphosol
Baking SodaOTHER

Oral rinse of baking soda solution as per standard of care five times daily beginning on day one of chemotherapy.

Also known as: Sodium Bicarbonate
Baking Soda

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

SarcomaStomatitisNeoplasmsMucositis

Interventions

calcium phosphateSodium Bicarbonate

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeMouth DiseasesStomatognathic DiseasesGastroenteritisGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium Compounds

Study Officials

  • Saroj Vadhan-Raj, MD

    UT MD Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2009

First Posted

August 25, 2009

Study Start

April 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

March 22, 2012

Record last verified: 2012-03

Locations

US(1)