CancerPhase 2NCT02807337
Supersaturated Calcium Phosphate Oral Rinse (Caphosol®) For the Prevention of Oral Mucositis in Children Undergoing Chemotherapeutic Treatments
A Phase 2 study testing Caphosol and 0,9% NaCl in people with Cancer, run by Tampere University Hospital at 3 sites in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Cancer
- What is being tested?
- Caphosol and 0,9% NaCl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 3 sitesFinland
- Study dates
- 1 Aug 2016to 31 Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric cancer patients aged 2 - 17.99 years old
- Patients diagnosed with solid or hematological malignancy and receiving chemotherapeutic drugs.
- Use of the following mucosa-breaking chemotherapeutic drugs: high-dose methotrexate, any anthracycline (doxorubicin, daunorubicin, idarubicin, mitoxantrone), and cisplatin.
- Protocol must include potential mucosa-breaking chemotherapeutic cycles at least twice in the protocol.
Who cannot join
- Patients younger than 2 years old or older than 18 years.
- Patients who have mucositis at the start of chemotherapeutic regimen.
- Less than three weeks from previous treatment ("washout" period).
- High-dose chemotherapy with stem cell transplantation patients.
- Induction treatment (leukemia).
Trial locations and contacts
3 sites in 1 country.
Finland3 sites
Kuopio University Hospital
Kuopio
Tampere University Hospital
Tampere
Turku University Hospital
Turku
About this study
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Caphosol, 0,9% NaCl
- Keywords
- Oral mucositis
- Medical subject headings
- Neoplasms, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaphosolDrug
0,9% NaClDrug
| Study group | Role | What they receive |
|---|---|---|
| Caphosol rinse group | Experimental | 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. Receives: Drug: Caphosol |
| 0,9% NaCl group. | Active comparator | 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. Receives: Drug: 0,9% NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study start1 Aug 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Turku University Hospital, Kuopio University Hospital
- Responsible party
- Sponsor
- Investigators
- Egle Immonen, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807337
- Sponsor's protocol ID
- R16021
- Status last verified
- Jan 2020
- First submitted
- 7 Jun 2016
- Last updated
- 20 Feb 2020
- Results posted
- No
Publications
Immonen E, Paulamaki L, Piippo H, Nikkila A, Aine L, Peltomaki T, Lohi O, Parikka M. Oral microbiome diversity and composition before and after chemotherapy treatment in pediatric oncology patients. BMC Oral Health. 2025 Jul 2;25(1):981. doi: 10.1186/s12903-025-06405-4.
PubMed 40604730Immonen E, Aine L, Nikkila A, Parikka M, Gronroos M, Vepsalainen K, Palmu S, Helminen M, Peltomaki T, Lohi O. Randomized controlled and double-blinded study of Caphosol versus saline oral rinses in pediatric patients with cancer. Pediatr Blood Cancer. 2020 Oct;67(10):e28520. doi: 10.1002/pbc.28520. Epub 2020 Jul 29.
PubMed 32725875
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supersaturated Calcium Phosphate Oral Rinse (Caphosol®) For the Prevention of Oral Mucositis in Children Undergoing Chemotherapeutic Treatments
- ClinicalTrials.gov ID
- NCT02807337
- Acronym / sponsor ID
- R16021
- Conditions
- Cancer
- Keywords
- Oral mucositis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Turku University Hospital, Kuopio University Hospital
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caphosol rinse group | Experimental | Drug: CaphosolCaphosol 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. |
| 0,9% NaCl group. | Active comparator | Drug: 0,9% NaCl0,9% 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. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pediatric cancer patients aged 2 - 17.99 years old
- Patients diagnosed with solid or hematological malignancy and receiving chemotherapeutic drugs.
- Use of the following mucosa-breaking chemotherapeutic drugs: high-dose methotrexate, any anthracycline (doxorubicin, daunorubicin, idarubicin, mitoxantrone), and cisplatin.
- Protocol must include potential mucosa-breaking chemotherapeutic cycles at least twice in the protocol.
Key exclusion criteria (5 listed)
- Patients younger than 2 years old or older than 18 years.
- Patients who have mucositis at the start of chemotherapeutic regimen.
- Less than three weeks from previous treatment ("washout" period).
- High-dose chemotherapy with stem cell transplantation patients.
- Induction treatment (leukemia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caphosol | Drug | Caphosol rinse group |
| 0,9% NaCl | Drug | 0,9% NaCl group. |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Derived from this study: PubMed 40604730Immonen E, Paulamaki L, Piippo H, Nikkila A, Aine L, Peltomaki T, Lohi O, Parikka M. Oral microbiome diversity and composition before and after chemotherapy treatment in pediatric oncology patients. BMC Oral Health. 2025 Jul 2;25(1):981. doi: 10.1186/s12903-025-06405-4.
- Derived from this study: PubMed 32725875Immonen E, Aine L, Nikkila A, Parikka M, Gronroos M, Vepsalainen K, Palmu S, Helminen M, Peltomaki T, Lohi O. Randomized controlled and double-blinded study of Caphosol versus saline oral rinses in pediatric patients with cancer. Pediatr Blood Cancer. 2020 Oct;67(10):e28520. doi: 10.1002/pbc.28520. Epub 2020 Jul 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Egle Immonen principal investigator
Tampere University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Caphosol and 0,9% NaCl in people with Cancer, run by Tampere University Hospital at 3 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02807337, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020; AzTrials last refreshed its copy on 7 Nov 2026.