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

NCT02539342 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2020-03-09

Study results available
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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.

Conditions

  • Oral Mucositis

Interventions

DRUG

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 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

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.

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Michael E Burke, MD · Medical College of Wisconsin

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-03-02
Completion
2017-03-02

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02539342 on ClinicalTrials.gov