Oral MucositisPhase 1/2NCT00901732
Caphosol for the Reduction of Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer
A Phase 1/2 study testing Caphosol in people with Oral Mucositis, run by Jazz Pharmaceuticals at 6 sites in United States.
Trial summary
Patients who have been diagnosed with a head and/or neck cancer commonly develop oral mucositis (OM). The purpose of this study is to estimate the effect of Caphosol on OM and to evaluate if Caphosol had any effect on clinical outcomes which include quality of life, oral intake, swallowing function and pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- Caphosol
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 100 participants
- Where
- 6 sitesUnited States
- Study dates
- May 2009to Nov 2010
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed Head and Neck Cancer patients with planned Radiation therapy
- Have at least one of 10 pre-defined anatomic mucosal subsites on view
- Age >/= 18 years
- Life expectancy >/= 6 months
- Planned RT to the head/neck
- Must be able to perform oral rinse
Who cannot join
- Active infections of oral cavity
- physiologic condition that precludes the use of an oral rinse
- Hypersensitivity to Caphosol ingredients
- Presence of mucosal ulceration at baseline
- Poorly controlled hypertension, DM or other serious medical/psychiatric illness
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
David Brizel, MD
- Recruiting
University of Florida College of Medicine
Gainesville, Florida, 32610
Robert Amdur, MD
Bridgett Fitzgerald
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Mark Chambers, MD
- Recruiting
Beth Israel Medical Center
New York, New York, 10003
Kenneth Hu, MD
- Recruiting
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Curtis T Miyamoto, MD
Jennifer Curry, RN
- Recruiting
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
Andy Trotti, MD, 813-745-8424
Margaret Lotrimare, 813-745-7223, margaret.lomartire@moffitt.org
About this study
Patients who have been diagnosed with a head and/or neck cancer commonly develop oral mucositis (OM). The purpose of this study is to estimate the effect of Caphosol on OM and to evaluate if Caphosol had any effect on clinical outcomes which include quality of life, oral intake, swallowing function and pain.
- Conditions
- Oral Mucositis
- Being tested
- Caphosol
- Keywords
- Caphosol, Oral Mucositis, Eusa Pharma, Moffitt Cancer Center
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaphosolDevice
Also called supersaturated solution of calcium and phosphate ions.
Oral Mouth Rinse
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to estimate ht incidence of OM in H&N cancer patients undergoing radiation therapy with or without chemotherapy and/or sensitizer who receive Caphosol.
Measured: 15 weeks
Secondary outcomes (1)
The secondary objective of this study is to correlate components of OM data with clinical outcomes (pain, narcotic use, oral intake)
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2009 (estimated)
- Study startMay 2009
- Primary completionNov 2010 (estimated)
- Study completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe 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 1/2
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andy M Trotti, MD, Principal investigator, Moffitt Cancer Center, Tampa FloridaDavid M Brizel, MD, Study director, Duke University, Durham, North CarolinaDavid I Rosenthal, MD, Principal investigator, MD Anderson Cancer Center, Houston, TexasMark Chambers, MD, Study director, MD Anderson Cancer Center, Houston, TexasCurtis T Miyamoto, MD, Study director, Temple University Hospital, Philadelphia, PAKenneth Hu, MD, Study director, Beth Israel Medical Center, New York, New YorkRobert Amdur, MD, Study director, University of Florida, Gainesville, Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901732
- Sponsor's protocol ID
- 603EUSA03
- Status last verified
- May 2009
- First submitted
- 13 May 2009
- Last updated
- 14 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caphosol for the Reduction of Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00901732
- Acronym / sponsor ID
- 603EUSA03
- Conditions
- Oral Mucositis
- Keywords
- Caphosol, Oral Mucositis, Eusa Pharma, Moffitt Cancer Center
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 14 May 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.
Patients who have been diagnosed with a head and/or neck cancer commonly develop oral mucositis (OM). The purpose of this study is to estimate the effect of Caphosol on OM and to evaluate if Caphosol had any effect on clinical outcomes which include quality of life, oral intake, swallowing function and pain.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed Head and Neck Cancer patients with planned Radiation therapy
- Have at least one of 10 pre-defined anatomic mucosal subsites on view
- Age >/= 18 years
- Life expectancy >/= 6 months
- Planned RT to the head/neck
Key exclusion criteria (5 listed)
- Active infections of oral cavity
- physiologic condition that precludes the use of an oral rinse
- Hypersensitivity to Caphosol ingredients
- Presence of mucosal ulceration at baseline
- Poorly controlled hypertension, DM or other serious medical/psychiatric illness
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: supersaturated solution of calcium and phosphate ions.Oral Mouth Rinse | Device | – |
Primary outcome
The primary objective is to estimate ht incidence of OM in H&N cancer patients undergoing radiation therapy with or without chemotherapy and/or sensitizer who receive Caphosol.
Time frame: 15 weeks
1 secondary outcome
The secondary objective of this study is to correlate components of OM data with clinical outcomes (pain, narcotic use, oral intake)
Time frame: 15 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2009.
Related trials for Oral Mucositis
Not yet recruiting
Recurrent Aphthous Stomatitis Management in Children Using Diode Laser 980 Nanometer Versus Hyaluronic Acid Gel (RCT)
Apthous Ulcer
RecruitingPhase 2
Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.
Radiotherapy-induced Oral Mucositis
RecruitingPhase 3
High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma, Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
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.
Andy M Trotti, MD principal investigator
Moffitt Cancer Center, Tampa Florida
David M Brizel, MD study director
Duke University, Durham, North Carolina
David I Rosenthal, MD principal investigator
MD Anderson Cancer Center, Houston, Texas
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Caphosol in people with Oral Mucositis, run by Jazz Pharmaceuticals at 6 sites 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Manyak, MD (609-750-8200, michael.manyak@eusapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective is to estimate ht incidence of OM in H&N cancer patients undergoing radiation therapy with or without chemotherapy and/or sensitizer who receive Caphosol. (time frame: 15 weeks). 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 14 May 2009.