Supersaturated Calcium Phosphate Oral Rinse (Caphosol®) For the Prevention of Oral Mucositis in Children Undergoing Chemotherapeutic Treatments

February 19, 2020 updated by: Tampere University Hospital
Prospective double-blinded randomized clinical study. Aim of the study is to compare the effectiveness of Caphosol mouth rinses in prevention of oral mucositis as compared to 0.9% NaCl rinses. Patients will be randomized to receive either Caphosol or 0.9% NaCl rinses four times a day for seven days from the beginning of chemotherapeutic regimen. The same patient will be given the opposite rinse during the next chemotherapeutic regimen, so everyone will get both mouth rinses once during the trial.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will be a double-blinded study so that the researchers or research nurses and the patients/parents are unaware of the solution used (Caphosol vs 0.9% NaCl). They both taste very similar and are packaged to ampules similar to each other. Since Caphosol consists of two solutions (A and B) which are mixed immediately before use, the investigators will apply the same procedure also in case of 0.9% NaCl solution (two vials of 0.9% NaCl will be mixed) to maintain blinding. Caphosol and 0.9% NaCl rinses will be relabeled to maintain blinding. Every patient will participate two times in the study. The treatment group allocation is based on randomization and will be performed once before participation for the first time. During another chemotherapeutic regimen, the same patient will automatically use another mouth rinse (Group 1 => Group 2 and Group 2 => Group 1). This dependence-effect caused by observations gathered from same patients will be taken into account when analysing the data. Blinding will be maintained throughout the study.

The investigators estimate that occurrence of oral mucositis as a side effect of chemotherapeutic treatment differs by 3-fold in different study arms (10% in Caphosol group, and 30% in 0.9% NaCl group). Power calculations using power of 0.8 and p-value of 0.05 indicate that the 70 children are needed to be recruited into each arm, i.e. two repeated measurements from 70 children are needed to have adequate statistical power. A drop-out of approximately 3-5% of patients has been taken into account and therefore the investigators plan to recruit 75 patients. Randomization will be performed using freely available and web-based MINIM-randomization software.

The data analysis will be performed on intention-to-treat principle. Mixed-effect regression methods will be used due to repeated observation within study subjects.

Specific methods used for this study:

  • Oral mucositis will be assessed daily for all patients at the oncology ward and at home by use of the Children International Mucositis Evaluation Scale and World Health Organization oral mucositis scale.
  • In the beginning of study, initial clinical evaluation will be performed by a pediatric dentist. During the stay at hospital, parents/patients (or nurses) will fill in the oral mucositis scales. At home, the patients/parents fill the scales. Scales will be filled in once a day for 14 consecutive days. Caphosol / 0.9% NaCl rinse treatment will last for only 7 consecutive days.
  • The available medical and dental records will be audited for the frequency of oral mucositis.
  • Oral samples will be collected by a pediatric dentist, and bacterial analyses will be performed by microbiologist at University of Tampere.
  • Laboratory values and pain medications will be retrieved from electronic patient files (MIRANDA/Fimlab).
  • Blood tests will be collected for possible later use in genetic studies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Kuopio, Finland
        • Kuopio University Hospital
      • Tampere, Finland
        • Tampere University Hospital
      • Turku, Finland
        • Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Pediatric cancer patients aged 2 - 17.99 years old
  2. Patients diagnosed with solid or hematological malignancy and receiving chemotherapeutic drugs.
  3. Use of the following mucosa-breaking chemotherapeutic drugs: high-dose methotrexate, any anthracycline (doxorubicin, daunorubicin, idarubicin, mitoxantrone), and cisplatin.
  4. Protocol must include potential mucosa-breaking chemotherapeutic cycles at least twice in the protocol.

Exclusion Criteria:

  1. Patients younger than 2 years old or older than 18 years.
  2. Patients who have mucositis at the start of chemotherapeutic regimen.
  3. Less than three weeks from previous treatment ("washout" period).
  4. High-dose chemotherapy with stem cell transplantation patients.
  5. Induction treatment (leukemia).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Caphosol rinse group
Caphosol consists of two solutions (A and B) which are mixed immediately before use. Caphosol mouth rinse will begin concomitantly (the same day) with the beginning of chemotherapeutic drugs. It will be continued for seven consecutive days.
Drug: Caphosol
Active Comparator: 0,9% NaCl group.
0,9% NaCl consists of two solutions (A and B). Two vials of 0.9% NaCl will be mixed to maintain blinding. The study mouth rinse will begin concomitantly (the same day) with the beginning of chemotherapeutic drugs. It will be continued for seven consecutive days.
Drug: 0,9% NaCl

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Oral mucositis will be assessed daily for all 75 pediatric patients at the oncology ward and at home by use of the Children International Mucositis Evaluation Scale (ChIMES scale) and WHO oral mucositis scale.
Time Frame: 3 years
ChIMES Scale - illustrations of faces with expressions corresponding to the following scores:children will select the face that best describes how they are feeling. Oral samples will be collected by a pediatric dentist, and bacterial analyses will be performed later on. Also, blood tests will be collected for possible later use in genetic studies.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tampere University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Turku University Hospital
Kuopio University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Egle Immonen, Tampere University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R16021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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