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Lack of funding
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caphosol | Drug | Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day as follows:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of Four Times Daily Caphosol Therapy | Any adverse events attributable to caphosol therapy being given 4 times daily | 24 months |
Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael E Burke, MD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Caphosol Arm | 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 diary to record symptoms of oral mucositis. Caphosol: Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day as follows:
|
| FG001 | Control Arm | 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) 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
We had only 1 enrollment overall and that was to the Caphosol arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Caphosol Arm | 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 diary to record symptoms of oral mucositis. Caphosol: Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day as follows:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | We only had 1 patient enrolled on the Caphosol Arm and none on the Control Arm | Posted | Count of Participants | Participants | 24 months |
|
4 months - but there were no adverse events
There were no adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Caphosol Arm | 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. Caphosol: 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. o • Patients may use Biotene (5-10 mL) to swish and spit after the 15 minutes has passed |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael J Burke, MD | Medical College of Wisconsin | 414-955-4170 | mmburke@mcw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 24, 2016 | Dec 11, 2018 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 9, 2016 | Feb 18, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D012464 | Saliva, Artificial |
| C111669 | Biotene |
| ID | Term |
|---|---|
| D009067 | Mouthwashes |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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|
| Biotene | Drug | • 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. |
|
| BG001 | Control Arm | 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) 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control Arm | 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) 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. |
|
|
| Other Pre-specified | Tolerability of Four Times Daily Caphosol Therapy | Any adverse events attributable to caphosol therapy being given 4 times daily | 1 patient enrolled on Caphosol and None on Control Arm | Posted | Number | events | 24 months |
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| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Control Arm | 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) 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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