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

NCT02539342 | Terminated Phase 3 Results DMC

• 1 other identifier: Caphosol Study
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Oral Mucositis; Cancer; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (1)

• Tolerability of Four Times Daily Caphosol Therapy

  24 months

Study Arms (2)

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.

Drug: Caphosol

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)

Drug: Biotene

Interventions

Caphosol DRUG

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

Also known as: artificial saliva, Supersaturated calcium phosphate rinse

Caphosol Arm

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.

Control Arm

Eligibility Criteria

• Age: Up to 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Stomatitis; Neoplasms

Interventions

Saliva, Artificial; Biotene

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Mouthwashes; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Michael J Burke, MD
• Organization: Medical College of Wisconsin

mmburke@mcw.edu

414-955-4170

Study Officials

• Michael E Burke, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: August 20, 2015
• First Posted: September 3, 2015
• Study Start: October 1, 2016
• Primary Completion: March 2, 2017
• Study Completion: March 2, 2017
• Last Updated: March 9, 2020
• Results First Posted: August 1, 2019

Record last verified: 2020-02

Locations

US (1)