SarcomaPhase 2NCT00965172
Caphosol in Sarcoma Patients With Mucositis
A Phase 2 study testing Caphosol and Baking Soda in people with Sarcoma and Oral Mucositis, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Sarcoma, Oral Mucositis
- What is being tested?
- Caphosol and Baking Soda
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Feb 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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 of the mouth, throat, and intestines). Researchers want to compare the effects of calcium phosphate and baking soda on patients who are at risk for mucositis.
The Study Drugs:
Caphosol (calcium phosphate) is a saliva-like liquid that is designed to replace the chemical and pH (acid) balance in the mouth. It is used as a mouth rinse to moisten, lubricate, and clean the mouth, including the lining of the mouth, tongue, and throat. It is also used to loosen thick mucous and help prevent the mucous membranes from sticking together.
Baking soda is used as the standard of care for preventing and treating mucositis.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to receive either calcium phosphate mouth rinse or the baking soda mouth rinse during the study. There is an equal chance of being assigned to either group.
You will use the mouth rinse 5 times every day. The study staff will explain how to mix and rinse with it.
Calcium phosphate should be stored at room temperature and should not be refrigerated. If you are on a low sodium diet, you should check with your doctor before using calcium phosphate.
Baseline Tests:
The following tests and procedures will be performed before you receive your first dose of chemotherapy:
- Blood (about 3 teaspoons) will be drawn for routine tests.
- The mucous membranes in your mouth will be checked.
- You will be asked to complete a questionnaire (about 15 minutes) on how you feel.
- You will be given a diary before you start each cycle to record if you have any mouth pain.
Study Tests:
You will need to come to MD Anderson on around Days 10, 12, and 14 (depending on the status of the mucositis) of each chemotherapy cycle. During these clinic visits, the following tests and procedures may be performed:
- You will have a physical exam, including measurement of your vital signs and weight.
- Blood (about 3 teaspoons) will be drawn for routine tests.
- The mucous membranes in your mouth will be checked. Also, you may have your mouth and throat photographed.
- You will be asked to complete the questionnaire on how you feel.
- When possible, the optical imaging procedures will also be performed on these days.
Length of Study and Reasons for Leaving the Study Early:
You will take part in this study for up to 18 weeks (4 to 5 months). You will be taken off study if you experience intolerable side effects.
End of Study Visit:
You will also have an end of study visit after you complete 6 cycles of study drug, if you are taken off study for any reason, or if you choose to leave the study. During this visit, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs and weight.
- Blood (about 3 teaspoons) will be drawn for routine tests.
- The mucous membranes in your mouth will be checked.
- You will be asked to complete the questionnaire on how you feel.
- You will receive a phone call from the nurse after you last dose of study drug to follow up on any side effects.
This is an investigational study. Caphosol (calcium phosphate) is FDA approved and commercially available for use in preventing and treating mucositis, and for relief of dry mouth during high dose chemotherapy or radiation treatment.
Up to 30 patients will take part in this study. All will be enrolled at M. D Anderson.
- Conditions
- Sarcoma, Oral Mucositis
- Being tested
- Caphosol, Baking Soda
- Keywords
- Cancer, Mucositis, Chemotherapy, Caphosol, Calcium phosphate, Sodium Bicarbonate, Baking Soda Solution, Multi-cycle chemotherapy
- Medical subject headings
- Sarcoma, Stomatitis, Neoplasms, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaphosolOther
Also called calcium phosphate
Oral rinse of calcium phosphate solution five times daily beginning on day one of chemotherapy.
Baking SodaOther
Also called Sodium Bicarbonate
Oral rinse of baking soda solution as per standard of care five times daily beginning on day one of chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Caphosol | Experimental | Caphosol (calcium phosphate) Receives: Other: Caphosol |
| Baking Soda | Active comparator | Control Group (standard of care) Receives: Other: Baking Soda |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence/Severity of Oral Mucositis WHO Grades 1, 2, 3, and 4
Measured: Incidence of mucositis (all grades) within 6 cycles of treatment (estimate 18 weeks, 4 to 5 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startApr 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saroj Vadhan-Raj, MD, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965172
- Sponsor's protocol ID
- 2008-0276
- Status last verified
- Mar 2012
- First submitted
- 21 Aug 2009
- Last updated
- 22 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00965172
- Acronym / sponsor ID
- 2008-0276
- Conditions
- Sarcoma, Oral Mucositis
- Keywords
- Cancer, Mucositis, Chemotherapy, Caphosol, Calcium phosphate, Sodium Bicarbonate, Baking Soda Solution, Multi-cycle chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 25 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 of the mouth, throat, and intestines). Researchers want to compare the effects of calcium phosphate and baking soda on patients who are at risk for mucositis.
The Study Drugs:
Caphosol (calcium phosphate) is a saliva-like liquid that is designed to replace the chemical and pH (acid) balance in the mouth. It is used as a mouth rinse to moisten, lubricate, and clean the mouth, including the lining of the mouth, tongue, and throat. It is also used to loosen thick mucous and help prevent the mucous membranes from sticking together.
Baking soda is used as the standard of care for preventing and treating mucositis.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to receive either calcium phosphate mouth rinse or the baking soda mouth rinse during the study. There is an equal chance of being assigned to either group.
You will use the mouth rinse 5 times every day. The study staff will explain how to mix and rinse with it.
Calcium phosphate should be stored at room temperature and should not be refrigerated. If you are on a low sodium diet, you should check with your doctor before using calcium phosphate.
Baseline Tests:
The following tests and procedures will be performed before you receive your first dose of chemotherapy:
- Blood (about 3 teaspoons) will be drawn for routine tests.
- The mucous membranes in your mouth will be checked.
- You will be asked to complete a questionnaire (about 15 minutes) on how you feel.
- You will be given a diary before you start each cycle to record if you have any mouth pain.
Study Tests:
You will need to come to MD Anderson on around Days 10, 12, and 14 (depending on the status of the mucositis) of each chemotherapy cycle. During these clinic visits, the following tests and procedures may be performed:
- You will have a physical exam, including measurement of your vital signs and weight.
- Blood (about 3 teaspoons) will be drawn for routine tests.
- The mucous membranes in your mouth will be checked. Also, you may have your mouth and throat photographed.
- You will be asked to complete the questionnaire on how you feel.
- When possible, the optical imaging procedures will also be performed on these days.
Length of Study and Reasons for Leaving the Study Early:
You will take part in this study for up to 18 weeks (4 to 5 months). You will be taken off study if you experience intolerable side effects.
End of Study Visit:
You will also have an end of study visit after you complete 6 cycles of study drug, if you are taken off study for any reason, or if you choose to leave the study. During this visit, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs and weight.
- Blood (about 3 teaspoons) will be drawn for routine tests.
- The mucous membranes in your mouth will be checked.
- You will be asked to complete the questionnaire on how you feel.
- You will receive a phone call from the nurse after you last dose of study drug to follow up on any side effects.
This is an investigational study. Caphosol (calcium phosphate) is FDA approved and commercially available for use in preventing and treating mucositis, and for relief of dry mouth during high dose chemotherapy or radiation treatment.
Up to 30 patients will take part in this study. All will be enrolled at M. D Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caphosol | Experimental | Other: CaphosolCaphosol (calcium phosphate) |
| Baking Soda | Active comparator | Other: Baking SodaControl Group (standard of care) |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaphosolAlso: calcium phosphateOral rinse of calcium phosphate solution five times daily beginning on day one of chemotherapy. | Other | Caphosol |
| Baking SodaAlso: Sodium BicarbonateOral rinse of baking soda solution as per standard of care five times daily beginning on day one of chemotherapy. | Other | Baking Soda |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2012.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saroj Vadhan-Raj, MD study chair
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Caphosol and Baking Soda in people with Sarcoma and Oral Mucositis, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2012.