NCT02807337

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for phase_2 cancer

Timeline
Completed

Started Aug 2016

Typical duration for phase_2 cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 20, 2020

Status Verified

January 1, 2020

Enrollment Period

3.4 years

First QC Date

June 7, 2016

Last Update Submit

February 19, 2020

Conditions

Cancer

Keywords

Oral mucositis

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 years

Study Arms (2)

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.

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.

Drug: 0,9% NaCl

Interventions

CaphosolDRUG
Caphosol rinse group
0,9% NaClDRUG
0,9% NaCl group.

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kuopio University Hospital

Kuopio, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Turku University Hospital

Turku, Finland

Location

Related Publications (2)

  • 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.

    PMID: 40604730DERIVED

  • Immonen 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.

    PMID: 32725875DERIVED

MeSH Terms

Conditions

NeoplasmsStomatitis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Egle Immonen

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2016

First Posted

June 21, 2016

Study Start

August 1, 2016

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

February 20, 2020

Record last verified: 2020-01

Locations

FI(3)