Oral Mucositis Clinical Trial
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
Verified date | February 2020 |
Source | Medical College of Wisconsin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 1 |
Est. completion date | March 2, 2017 |
Est. primary completion date | March 2, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 25 Years |
Eligibility |
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: - Actinomycin D - Carboplatin - Cisplatin - Cytarabine at doses > 1 gram/m2 - 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care Exclusion Criteria: - Patients receiving glutamine treatment for oral mucositis.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 |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital of Wisconsin | Milwaukee | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Medical College of Wisconsin |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Tolerability of Four Times Daily Caphosol Therapy | Any adverse events attributable to caphosol therapy being given 4 times daily | 24 months | |
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 | 24 months |
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