Oral MucositisPhase 3NCT02539342
Caphosol Study: Prevention of Oral Mucositis in Children, Adolescents and Young Adults Receiving Chemotherapy
A Phase 3 study testing Caphosol and Biotene in people with Oral Mucositis, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The purpose of this study is to determine if the administration of Caphosol rinse, at the start of chemotherapy, will prevent the development of mucositis (greater than or equal to grade 2 in children, adolescents and young adults. This is a randomized, controlled trial. Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- Caphosol and Biotene
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 2 Mar 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Oncology patients, at initiation of their oncology therapy, who are at risk of developing oral mucositis during their scheduled cancer therapy, defined by meeting one or more of the following criteria:
- Patients receiving one or more of the following chemotherapy agents:
- Actinomycin D
- Carboplatin
- Cisplatin
- Cytarabine at doses > 1 gram/m2
Show all 12Show fewer
- Daunorubicin
- Doxorubicin
- Methotrexate at doses > 1 gram/m2
- Mitoxantrone
- Age 0 to 25 years
- Voluntary written consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Who cannot join
- Patients receiving glutamine treatment for oral mucositis.
- Patients undergoing autologous or allogeneic hematopoietic cell transplantation are excluded from this study.
- Patients receiving concurrent Head \& Neck radiation therapy or within 6 weeks of completion of radiation therapy.
- Pregnant or lactating patients. The agent used in this study is not known to be teratogenic to a fetus, but has not been studies, and there is no information on the excretion of the agent into breast milk. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy.
- Known allergy to Caphosol
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Caphosol Study: A Randomized Controlled Open-Labeled Trial Investigating Topical Caphosol for Prevention of Oral Mucositis in Children, Adolescents and Young Adults Receiving Chemotherapy
The purpose of this study is to determine if the administration of Caphosol rinse, at the start of chemotherapy, will prevent the development of mucositis (greater than or equal to grade 2 in children, adolescents and young adults. This is a randomized, controlled trial.
Read the detailed description
Oral mucositis, is a common and debilitating complication of cancer therapy. It is an inflammatory injury to the epithelial and sub-epithelial cells of the oral mucosa. The incidence and severity of oral mucositis depends on many factors including the age and diagnosis of the patient, the specific treatment regimen, underlying oral hygiene and genetic factors 2-4. This ranges from around 40% of patients getting chemotherapy for solid tumors to 70-90% of patients getting chemotherapy for before stem cell transplant.
Oral mucositis causes significant pain, interferes with eating, talking and swallowing, significantly diminishes enteral nutritional intake and has a substantial negative impact on quality of life. Patients may require hospitalization for management of the complications of mucositis, including poor nutrition, dehydration and pain. Injury to the oral mucosa also increases the risk of systemic infections. Finally, the development of oral mucositis may require delays or dose reductions in future chemotherapy courses, potentially jeopardizing disease cure rates.
Despite all that is known about the mechanism, course and complications of oral mucositis, there are no consensus guidelines on prevention or treatment of chemotherapy-induced oral mucositis and there is significant variation on approach to mucositis across treatment centers.
Caphosol (Jazz Pharmaceuticals, Inc. Palo Alto, CA) was designed in part to replace the normal ionic and pH balance of the oral cavity and been used to prevent and/or treat oral mucositis. Caphosol is hypothesized to diffuse into epithelial intracellular spaces and permeate mucosal lesions in oral mucositis.
This study is a randomized, controlled trial evaluating the use of topical Caphosol therapy to prevent oral mucositis (Grade ≥ 2) in children, adolescents and young adults undergoing chemotherapy. At the time of enrollment, patients will be randomized to either the control arm or the Caphosol arm. The treatment period will extend from the start of chemotherapy and continue for 7 days after completion of chemotherapy AND until the ANC is > 500 after nadir (count recovery) or until the symptoms of oral mucositis resolve; whichever occurs last.
Study patients will be recruited from the MACC Fund Center and the oncology inpatient service. Study entry is open to patients regardless of gender or ethnic background. While there will be every effort to seek out and include females and minority patients, the patient population is expected to be no different than that of other oncology studies at the Medical College of Wisconsin.
- Conditions
- Oral Mucositis
- Being tested
- Caphosol, Biotene
- Keywords
- Oral Mucositis, Cancer, Chemotherapy
- Medical subject headings
- Stomatitis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaphosolDrug
Also called artificial saliva, Supersaturated calcium phosphate rinse
Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day as follows:
- Each dose consists of two 15 mL syringes, to be mixed at time of administration. Caphosol must be used within 15 minutes of mixing.
- Participants may increase the use to 6 times per day if you have symptoms of mucositis.
- Using one of the syringes, rinse and gargle (if patient is able) for one minute and then spit. Repeat using the remaining syringe.
- For younger patients (less than or equal to 6 years of age), volume may be reduced to two syringes containing 5-10 mL each.
- For patients unable to successfully rinse and spit, caregivers may paint their mouth (using medical sponge swabs) with the solution two times. Repeat using the second syringe.
- Patients are to avoid other oral medications, other mouth cares and food or drink for 15 minutes after using Caphosol.
- Patients may use Biotene (5-10 mL) to swish and spit after the 15 minutes has passed
BioteneDrug
- Use 5 to 10 mL of Biotene to swish and spit
- For patients unable to successfully rinse and spit, caregivers may paint their mouth (using medical sponge swabs) with the solution two times. Prior to swabbing the patient's mouth, pour Biotene into a cup and using the medical sponge, soak up the solution and use the swab to coat the inside of the patient's mouth. Repeat with a second swab.
| Study group | Role | What they receive |
|---|---|---|
| Caphosol Arm | Experimental | Caphosol Arm: Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day from the start of chemotherapy until 7 days after the completion of chemotherapy AND until the ANC is >500 after count recovery OR until the the symptoms or oral mucositis resolve, whichever occurs last. Patients will also complete a study diary to record symptoms of oral mucositis. Receives: Drug: Caphosol |
| Control Arm | Active comparator | Control Arm: Subjects randomized to the Control Arm will use Biotene 4 times per day. They will also complete a study diary to record doses and any symptoms of oral mucositis. This will begin at the start of chemotherapy until for 7 days AND until ANC >500 after nadir or oral mucositis resolves (whichever occurs later) Receives: Drug: Biotene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the Development of Oral Mucositis (Grade >/= 2) in Children, Adolescents and Young Adults.
The development of Mucositis Grade >/= 2 in children receiving chemotherapy as evaluated using CTCAE 4.0
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startOct 2016
- Primary completion2 Mar 2017
- Study completion2 Mar 2017
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Burke, Medical College of Wisconsin
- Investigators
- Michael E Burke, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539342
- Sponsor's protocol ID
- Caphosol Study
- Status last verified
- Feb 2020
- First submitted
- 20 Aug 2015
- Last updated
- 9 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caphosol Study: A Randomized Controlled Open-Labeled Trial Investigating Topical Caphosol for Prevention of Oral Mucositis in Children, Adolescents and Young Adults Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT02539342
- Acronym / sponsor ID
- Caphosol Study
- Conditions
- Oral Mucositis
- Keywords
- Oral Mucositis, Cancer, Chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 2 Mar 2017 (actual)
- Study completion
- 2 Mar 2017 (actual)
- First posted
- 3 Sep 2015 (estimated)
- Results
- Posted 1 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the administration of Caphosol rinse, at the start of chemotherapy, will prevent the development of mucositis (greater than or equal to grade 2 in children, adolescents and young adults. This is a randomized, controlled trial.
Detailed description
Oral mucositis, is a common and debilitating complication of cancer therapy. It is an inflammatory injury to the epithelial and sub-epithelial cells of the oral mucosa. The incidence and severity of oral mucositis depends on many factors including the age and diagnosis of the patient, the specific treatment regimen, underlying oral hygiene and genetic factors 2-4. This ranges from around 40% of patients getting chemotherapy for solid tumors to 70-90% of patients getting chemotherapy for before stem cell transplant.
Oral mucositis causes significant pain, interferes with eating, talking and swallowing, significantly diminishes enteral nutritional intake and has a substantial negative impact on quality of life. Patients may require hospitalization for management of the complications of mucositis, including poor nutrition, dehydration and pain. Injury to the oral mucosa also increases the risk of systemic infections. Finally, the development of oral mucositis may require delays or dose reductions in future chemotherapy courses, potentially jeopardizing disease cure rates.
Despite all that is known about the mechanism, course and complications of oral mucositis, there are no consensus guidelines on prevention or treatment of chemotherapy-induced oral mucositis and there is significant variation on approach to mucositis across treatment centers.
Caphosol (Jazz Pharmaceuticals, Inc. Palo Alto, CA) was designed in part to replace the normal ionic and pH balance of the oral cavity and been used to prevent and/or treat oral mucositis. Caphosol is hypothesized to diffuse into epithelial intracellular spaces and permeate mucosal lesions in oral mucositis.
This study is a randomized, controlled trial evaluating the use of topical Caphosol therapy to prevent oral mucositis (Grade ≥ 2) in children, adolescents and young adults undergoing chemotherapy. At the time of enrollment, patients will be randomized to either the control arm or the Caphosol arm. The treatment period will extend from the start of chemotherapy and continue for 7 days after completion of chemotherapy AND until the ANC is > 500 after nadir (count recovery) or until the symptoms of oral mucositis resolve; whichever occurs last.
Study patients will be recruited from the MACC Fund Center and the oncology inpatient service. Study entry is open to patients regardless of gender or ethnic background. While there will be every effort to seek out and include females and minority patients, the patient population is expected to be no different than that of other oncology studies at the Medical College of Wisconsin.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caphosol Arm | Experimental | Drug: CaphosolCaphosol Arm: Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day from the start of chemotherapy until 7 days after the completion of chemotherapy AND until the ANC is >500 after count recovery OR until the the symptoms or oral mucositis resolve, whichever occurs last. Patients will also complete a study diary to record symptoms of oral mucositis. |
| Control Arm | Active comparator | Drug: BioteneControl Arm: Subjects randomized to the Control Arm will use Biotene 4 times per day. They will also complete a study diary to record doses and any symptoms of oral mucositis. This will begin at the start of chemotherapy until for 7 days AND until ANC >500 after nadir or oral mucositis resolves (whichever occurs later) |
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Oncology patients, at initiation of their oncology therapy, who are at risk of developing oral mucositis during their scheduled cancer therapy, defined by meeting one or more of the following criteria:
- Patients receiving one or more of the following chemotherapy agents:
- Age 0 to 25 years
- Voluntary written consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Key exclusion criteria (5 listed)
- Patients receiving glutamine treatment for oral mucositis.
- Patients undergoing autologous or allogeneic hematopoietic cell transplantation are excluded from this study.
- Patients receiving concurrent Head \& Neck radiation therapy or within 6 weeks of completion of radiation therapy.
- Pregnant or lactating patients. The agent used in this study is not known to be teratogenic to a fetus, but has not been studies, and there is no information on the excretion of the agent into breast milk. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy.
- Known allergy to Caphosol
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: artificial saliva, Supersaturated calcium phosphate rinseSubjects randomized to the Caphosol Arm will use Caphosol 4 times per day as follows: * Each dose consists of two 15 mL syringes, to be mixed at time of administration. Caphosol must be used within 15 minutes of mixing. o Participants may increase the use to 6 times per day if you have symptoms of mucositis. * Using one of the syringes, rinse and gargle (if patient is able) for one minute and then spit. Repeat using the remaining syringe. * For younger patients (less than or equal to 6 years of age), volume may be reduced to two syringes containing 5-10 mL each. * For patients unable to successfully rinse and spit, caregivers may paint their mouth (using medical sponge swabs) with the solution two times. Repeat using the second syringe. * Patients are to avoid other oral medications, other mouth cares and food or drink for 15 minutes after using Caphosol. * Patients may use Biotene (5-10 mL) to swish and spit after the 15 minutes has passed | Drug | Caphosol Arm |
| Biotene• Use 5 to 10 mL of Biotene to swish and spit o For patients unable to successfully rinse and spit, caregivers may paint their mouth (using medical sponge swabs) with the solution two times. Prior to swabbing the patient's mouth, pour Biotene into a cup and using the medical sponge, soak up the solution and use the swab to coat the inside of the patient's mouth. Repeat with a second swab. | Drug | Control Arm |
Primary outcome
Measure the Development of Oral Mucositis (Grade >/= 2) in Children, Adolescents and Young Adults.
Time frame: 24 months
The development of Mucositis Grade >/= 2 in children receiving chemotherapy as evaluated using CTCAE 4.0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Michael E Burke, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Caphosol and Biotene in people with Oral Mucositis, run by Medical College of Wisconsin 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 12 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: stopped early, as of the sponsor's last update on 9 Mar 2020. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Measure the Development of Oral Mucositis (Grade >/= 2) in Children, Adolescents and Young Adults. (time frame: 24 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 9 Mar 2020.