Caphosol Study: Prevention of Oral Mucositis in Children, Adolescents and Young Adults Receiving Chemotherapy

• Status: Terminated
• Trial end date: 2017-03-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical College of Wisconsin
• Treatments: Calcium

Criteria

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care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