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Study the effect of spray coldamaris in recovery of oral mucositis in stem cells transplantation patients

Protocol summary

Study aim
Study the effect of spray coldamaris in recovery of oral mucositis in SCT patients
Design
This clinical trial at Ghazi Tabatabaei Hospital in Tabriz involves 50 patients with myeloma, lymphoma, and acute leukemia undergoing bone marrow transplantation. Patients are randomly split into two groups of 25. The intervention group uses FDA-approved coldamaris spray three times daily for one week if mucositis occurs, while the control group receives no treatment. The study evaluates mucositis incidence, severity, and related clinical findings, comparing outcomes between groups.
Settings and conduct
This clinical trial was conducted on 50 patients with myeloma, lymphoma, and acute leukemia who were hospitalized in the transplant ward of Ghazi Tabatabaei Hospital in Tabriz over one year. After bone marrow transplantation, patients were evaluated for the incidence and severity of mucositis and its association with clinical and paraclinical findings. The patients were randomly divided into two groups of 25: control and intervention. Patients who developed mucositis in the intervention group used coldamaris spray (FDA-approved, Sec.172.620) three times daily for one week. Their outcomes were compared with the control group, which did not use the spray. The study aimed to compare the outcomes between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with myeloma, lymphoma, and acute leukemia in the HSCT ward of Ghazi Tabatabaei Hospital, Tabriz. Exclusion criteria: Patients unwilling to use coldamaris spray, pregnant patients, and patients with unstable hemodynamics.
Intervention groups
Patients with myeloma,lymphoma, acute leukemia
Main outcome variables
Severity of oral mucositis based on the WHO scale after the use of Coldamaris spray, duration of recovery, oral feeding status, and requirement for systemic analgesics.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160415027393N3
Registration date: 2025-07-15, 1404/04/24
Registration timing: registered_while_recruiting

Last update: 2025-07-15, 1404/04/24
Update count: 0
Registration date
2025-07-15, 1404/04/24
Registrant information
Name
Babak Nejati
Name of organization / entity
Internal medicine group of Tabriz medical university
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 2073
Email address
nejatib@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-06-10, 1404/03/20
Expected recruitment end date
2025-07-21, 1404/04/30
Actual recruitment start date
2025-06-12, 1404/03/22
Actual recruitment end date
2025-07-23, 1404/05/01
Trial completion date
2025-08-01, 1404/05/10
Scientific title
Study the effect of spray coldamaris in recovery of oral mucositis in stem cells transplantation patients
Public title
Study the effect of spray coldamaris in recovery of oral mucositis in stem cells transplantation patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
This study is a clinical study on 50 patients suffering from acute myeloma, pneumonia, and leukemia, who were hospitalized in the educational treatment ward of Shahid Ghazi Tabatabaei Hospital in Tabriz over the course of one year. After bone marrow transplantation, the mucositis incidence and severity were evaluated and its correlation with clinical and paraclinical findings was examined.
Exclusion criteria:
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 50
Actual sample size reached: 50
Randomization (investigator's opinion)
Randomized
Randomization description
The allocation of samples will be random, and the samples will be divided into control and intervention groups. In each group, 25 patients will be randomly selected. Patients who develop mucositis will use a solution of carrageenan (which has FDA approval under Sec. 172.620, and is also approved by the Iranian Food and Drug Organization and the FDA) three times daily for one week. The outcomes will be compared with a group of patients who develop mucositis but do not use this medication. A comparison of the results between the control and intervention groups will be performed.
Blinding (investigator's opinion)
Single blinded
Blinding description
In a single-blind study, the patient participates with full informed consent but does not know the specific name of the medication they are receiving among the possible treatment options.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2025-06-08, 1404/03/18
Ethics committee reference number
IR.TBZMED.REC.1404.263

Health conditions studied

1

Description of health condition studied
Study the effect of spray coldamaris in recovery of oral mucositis in stem cellstransplantation patients
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The primary outcome of the study is the improvement in the severity and extent of oral mucositis in patients undergoing stem cell transplantation, measured using a standard mucositis severity assessment scale (e.g., WHO Oral Mucositis Scale) on specific days after transplantation. Improvement includes the reduction of clinical symptoms of mucositis such as inflammation, pain, and oral ulcers.
Timepoint
days 1 to 21 after transplantation
Method of measurement
WHO Oral Mucositis Scale

Secondary outcomes

1

Description
The relationship between the severity of mucositis and laboratory markers, including ESR, LDH, fibrinogen, albumin, ferritin, and neutrophil count before transplantation, will be examined.
Timepoint
Evaluation with laboratory tests one to three days before transplantation
Method of measurement
Laboratory tests and Statistical methods

Intervention groups

1

Description
Intervention group: Patients with myeloma, lymphoma, leukemia
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Bone marrow transplant unit, Shahid Ghazi Tabatabaei Educational Therapeutic Hospital, Tabriz
Full name of responsible person
Babak nejati
Street address
Tabriz University of Medical Sciences, Faculty of Medicine
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3337 3207
Email
nejatib@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3337 3207
Email
nejatib@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Babak nejati
Position
Associate Professor at Tabriz University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Tabriz University of Medical Sciences, Faculty of Medicine
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3337 3207
Email
nejatib@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Babak nejati
Position
Associate Professor at Tabriz University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Tabriz University of Medical Sciences, Faculty of Medicine
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3337 3207
Email
nejatib@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Babak nejati
Position
Associate Professor at Tabriz University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Faculty of Medicine, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3337 3207
Email
nejatib@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because this study requires further extensive research.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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