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
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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