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Effectiveness of Coldamaris Oral Spray in Preventing and Reducing the Severity of Oral Mucositis in Children with Acute Lymphoblastic Leukemia Undergoing Chemotherapy A Randomized Controlled Clinical Trial

Protocol summary

Study aim
To evaluate the effectiveness of Coldamaris oral spray in preventing and reducing the severity of oral mucositis in children with acute lymphoblastic leukemia receiving chemotherapy
Design
Phase 3 randomized controlled clinical trial with two parallel groups and 80 participants, using 1:1 allocation with variable block randomization and blinded outcome assessment
Settings and conduct
The study is conducted at Amir Oncology Hospital, Shiraz. The intervention starts on the first day of induction chemotherapy and continues until the end of induction. The mucositis assessor is blinded to allocation
Participants/Inclusion and exclusion criteria
Children aged 1 to 18 years with newly diagnosed acute lymphoblastic leukemia scheduled for induction chemotherapy; major exclusions are hypersensitivity to Coldamaris, severe active oral lesions, diabetes, primary immunodeficiency, and concurrent malignancy
Intervention groups
The intervention group receives standard oral care plus Coldamaris oral spray, two sprays three times daily. The control group receives standard oral care alone
Main outcome variables
Incidence of severe grade 3 or 4 oral mucositis; maximum mucositis severity during induction chemotherapy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260815070650N1
Registration date: 2026-09-20, 1405/06/29
Registration timing: prospective

Last update: 2026-09-20, 1405/06/29
Update count: 0
Registration date
2026-09-20, 1405/06/29
Registrant information
Name
Ali Amanati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3632 3532
Email address
dr.amanati14@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-09-23, 1405/07/01
Expected recruitment end date
2027-09-21, 1406/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Coldamaris Oral Spray in Preventing and Reducing the Severity of Oral Mucositis in Children with Acute Lymphoblastic Leukemia Undergoing Chemotherapy A Randomized Controlled Clinical Trial
Public title
oral Clodamaris in the treatment of chemotherapy-induced mucositis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 1 and 18 years Confirmed diagnosis of acute lymphoblastic leukemia by a pediatric hematologist-oncologist Newly diagnosed acute lymphoblastic leukemia and being scheduled to start induction chemotherapy No previous anticancer treatment before enrollment Decision by the treating physician to initiate standard induction chemotherapy Adequate clinical and performance status to tolerate chemotherapy according to the treating physician Written informed consent provided by a parent or legal guardian Age-appropriate assent provided by children aged 7 years or older
Exclusion criteria:
Known or uncontrolled diabetes mellitus Absolute neutrophil count below 200 cells per microliter at baseline White blood cell count below 1000 cells per microliter at baseline History of severe hypersensitivity or known allergic reaction to Coldamaris or any of its components Presence of an active severe oral lesion at baseline that interferes with mucositis assessment Active severe oral herpes infection at baseline Extensive or multiple aphthous ulcers at baseline Severe or refractory oral candidiasis at baseline Presence of another concurrent malignancy Presence of a primary immunodeficiency disorder Critical clinical condition at baseline that makes oral examination or administration of the intervention impossible
Age
From 1 year old to 18 months old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be individually allocated to the intervention and control groups using variable block randomization with a 1:1 allocation ratio. The random allocation sequence will be generated by an independent person who is not involved in patient care using statistical software. Variable block sizes will be used to prevent prediction of future treatment assignments. The allocation sequence will be kept in sequentially numbered, opaque, sealed envelopes. After eligibility confirmation and obtaining informed consent, the responsible person will open the corresponding envelope to determine group allocation. Allocation concealment will be maintained until assignment to the study groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Because no placebo is used, participants, their parents or legal guardians, the principal investigator, and the clinical care team will not be blinded to group allocation. The outcome assessor responsible for evaluating the occurrence and severity of oral mucositis will be blinded to treatment allocation and will not be involved in participant allocation or intervention delivery.
Placebo
Not used
Assignment
Parallel
Other design features
This study is a two-arm, parallel, randomized controlled clinical trial with a 1:1 allocation ratio. Participants will be randomly assigned to either the intervention or control group. The intervention group will receive Coldamaris oral spray in addition to standard oral care, while the control group will receive standard oral care alone. Because no placebo is used, participants, parents, and the clinical care team will be aware of treatment allocation. However, the occurrence and severity of oral mucositis will be evaluated by a trained outcome assessor who is blinded to group allocation.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences, School of Medicine
Street address
Karim Khan Zand Blvd., School of Medicine, Shiraz University of Medical Sciences, Shiraz, Fars, Iran
City
shiraz
Province
Fars
Postal code
71348-14336
Approval date
2026-08-01, 1405/05/10
Ethics committee reference number
IR.SUMS.MED.REC.1405.185

Health conditions studied

1

Description of health condition studied
Acute Lymphoblastic Leukemia
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukemia [ALL]

2

Description of health condition studied
Oral Mucositis
ICD-10 code
K12.3
ICD-10 code description
Oral mucositis (ulcerative)

Primary outcomes

1

Description
Incidence of clinically significant oral mucositis of grade 2 or higher
Timepoint
Before the initiation of chemotherapy and on days 3, 7, 10, 14, and 21 after the start of induction chemotherapy, and whenever clinically significant oral symptoms occur
Method of measurement
Assessment and grading of oral mucositis using the World Health Organization Oral Toxicity Scale

2

Description
Incidence of severe oral mucositis of grade 3 or 4
Timepoint
Before the initiation of chemotherapy and on days 3, 7, 10, 14, and 21 after the start of induction chemotherapy, and whenever clinically significant oral symptoms occur
Method of measurement
Assessment and grading of oral mucositis using the World Health Organization Oral Toxicity Scale, the National Cancer Institute Common Terminology Criteria for Adverse Events, and the Western Consortium for Cancer Nursing Research Stomatitis Staging System

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Description: Participants will receive standard oral care in addition to Coldamaris oral spray containing iota carrageenan. The product used will be Coldamaris Rachenspray mit Carragelose, 20 mL, containing 1.2 mg of iota carrageenan, with approximately 0.14 mL delivered per spray. The intervention will start on the first day of induction chemotherapy. Participants will use two sprays three times daily, for a total of six sprays per day, applied locally to the oral mucosa and posterior pharyngeal wall. The spray will preferably be used after meals and after routine oral care. Participants will be advised to avoid eating, drinking, or rinsing the mouth for 20 minutes after administration. The intervention will continue until the end of the induction phase of chemotherapy, approximately four weeks. The product will be supplied by Tachra Pharmed Company.
Category
Prevention

2

Description
Control group: Participants will receive standard oral care according to the hospital protocol. Standard care includes oral hygiene education, mouth rinsing with normal saline or saline plus bicarbonate according to routine ward practice, and supportive care when clinically indicated. Participants in this group will not receive Coldamaris oral spray or any similar preventive topical product. If oral mucositis or other oral complications occur, necessary supportive treatments such as systemic analgesics, topical anesthetics, or nutritional interventions will be provided according to the treating physician's clinical judgment and will be recorded.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir Oncology Hospital
Full name of responsible person
Ali Amanati
Street address
Amir Oncology Hospital, Station 11, Farhang Shahr, Shiraz, Fars, Iran
City
shiraz
Province
Fars
Postal code
۷۱۸۷۹۱۵۹۹۸
Phone
+98 71 3632 3534
Email
amircrdc@sums.ac.ir
Web page address
https://amirhosp.sums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Deputy Director of Research and Technology
Street address
Vice President for Research and Technology, 7th Floor, Shiraz University of Medical Sciences Central Building, Zand Street, Shiraz, Fars, Iran
City
shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Web page address
https://research.sums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tachra Pharmed
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Amanati
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
Shiraz, Farhang Shahr, Station 11, Amir Oncology Hospital
City
shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2430
Fax
Email
dr.amanati14@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Amanati
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
Shiraz, Farhang Shahr, Station 11, Amir Oncology Hospital
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3632 3532
Fax
Email
dr.amanati14@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Amanati
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
Shiraz, Farhang Shahr, Station 11, Amir Oncology Hospital
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3632 3532
Fax
Email
dr.amanati14@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Deidentified individual participant data, including baseline variables, intervention-related data, oral mucositis assessments, primary and secondary outcomes, and adverse events, together with the study protocol, statistical analysis plan, informed consent form, final study report, and data dictionary, will be available for sharing. All direct identifiers and information that could reasonably permit participant identification will be removed before sharing.
When the data will become available and for how long
Access to the data and study documents will begin six months after publication of the main study results and will remain available for requests for five years following publication of the main results.
To whom data/document is available
Qualified researchers affiliated with universities, research centers, and recognized scientific institutions may request access. Requests from researchers in other organizations may also be considered when they have a clearly defined scientific purpose, meet applicable ethical requirements, and do not present an inappropriate conflict of interest.
Under which criteria data/document could be used
The data and documents may be used only for clearly defined scientific purposes, including secondary analyses, reanalysis of study findings, systematic reviews and meta-analyses, or other relevant scientific research. Applicants must provide a written research objective, research questions, and proposed analysis plan. Commercial use, attempts to reidentify participants, transfer of data to third parties without permission, and use beyond the approved purpose will not be permitted. Ethics approval from the applicant's institution and a data use agreement may be required when applicable.
From where data/document is obtainable
Requests should be submitted to the principal investigator, Dr. Ali Amanati, Shiraz University of Medical Sciences. The official contact information of the principal investigator provided in the clinical trial registry record will be used for correspondence.
What processes are involved for a request to access data/document
Applicants must submit a written request including the researcher's identity and institutional affiliation, the purpose of the request, research question, proposed analysis plan, and any required ethics documentation to the principal investigator. The request will be reviewed by the principal investigator and, when necessary, other members of the research team for scientific merit, ethical considerations, confidentiality, and consistency with the informed consent. A decision will normally be communicated within four weeks. Following approval and completion of any required data use agreement, the approved deidentified data or study documents will be provided electronically through a secure method.
Comments
No identifiable participant information will be shared. Data sharing will be subject to the informed consent provisions, ethics committee approval, and applicable regulations of Shiraz University of Medical Sciences.
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