Oral MucositisNCT07297472
Effect of Cold Application and Artificial Saliva in the Prevention of Chemotherapy-Induced Oral Mucositis
A study testing cold application and Artificial Saliva in people with Oral Mucositis, run by Karbala University.
Trial summary
the Objectives of this clinical trial is : 1. To determine the effect of Cold Application for preventing of chemotherapy-Induced oral mucositis in cancer patients. 2. To examine the effect of artificial saliva for preventing of chemotherapy-Induced oral mucositis in cancer patients. 3. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- cold application and Artificial Saliva
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who undergo chemotherapy.
- Patients who do not have oral mucositis.
- Patients who are aged 18 years and older.
- Patients who are male or female.
- Patients who agree to be included in the study sample.
Who cannot join
- Patients who was refused to participate in the study.
- Patients who was not undergoing chemotherapy.
- Patients how was undergoing chemo-radiotherapy.
- Patients who selected for pilot study.
- Patients diagnosed with oral mucositis.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Cold Application and Artificial Saliva in the Prevention of Chemotherapy-Induced Oral Mucositis in Patients With Cancer: A Randomized Controlled Trial
the Objectives of this clinical trial is :
- To determine the effect of Cold Application for preventing of chemotherapy-Induced oral mucositis in cancer patients.
- To examine the effect of artificial saliva for preventing of chemotherapy-Induced oral mucositis in cancer patients.
- To compare between the effect of artificial saliva and cold application for preventing of chemotherapy-Induced oral mucositis in cancer patients.
- To find out the differences between the effect of artificial saliva and cold application based on patient demographics and clinical data.
Read the detailed description
The non-keratinized mucosa of the oral cavity including the tongue, buccal mucosa, and lips is particularly susceptible to injury, leading to ulcerative lesions clinically known as oral mucositis (OM). This common and impactful toxicity of standard cancer therapy, characterized by mucosal damage that can range from mild inflammation to deep ulceration.
In cases CIOM, the severity often requires major clinical interventions, including diet modification, opioid analgesics, and nutritional supplementation, to avoid disrupting optimal cancer therapy. Furthermore, CIOM can lead to superinfection, with the additional threat of bacteremia and sepsis. Patients with OM are more likely to experience negative treatment outcomes , and higher healthcare costs compared to those without the condition.
Oral mucositis (OM) notably reduces quality of life by causing both physical and psychological distress. This condition can lead to serious psychological issues like anxiety, depression, and social isolation. Moreover, pre-existing anxiety and depression may serve as risk factors for the development of oral mucositis. (Borowski et al., 2025).
Although the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO) have recommended some strategies, our knowledge regarding the prevention and treatment of CIOM remains limited, with no established evidence-based management regimens. This underscores the need to develop novel therapeutic drugs and strategies .
Cold application, commonly described as the cooling of the mouth during chemotherapy. is a valuable tool for preventing OM in patients receiving certain chemotherapeutic agents. It is safe and well-tolerated, and it can help to reduce the risk of complications .
Patients undergoing chemotherapy often develop transient or permanent xerostomia (subjective symptom of dry mouth) and hyposalivation (objective reduction of salivary flow). Hyposalivation can elevate tissue inflammation and thus increase the risk of local infection and make mastication difficult.as a result increased risk of developing severe OM .
Artificial saliva works by forming a continuous, proactive, and hydrating film that helps prevent OM .Most clinical studies of artificial saliva only focused on signs and symptoms of dry mouth . However, the effect of artificial saliva on oral mucositis has not directly established yet.
While both interventions show individual promise, it is reasonable that their mechanisms of action are complementary. Cold application preventing the initial cytotoxic effect and artificial saliva protecting and healing the compromised mucosa. However, there are lack of the sufficient evidence evaluating their combined effect.
- Conditions
- Oral Mucositis
- Being tested
- cold application, Artificial Saliva
- Keywords
- Cold application, Artificial saliva
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold applicationOther
Also called oral cryotherapy
The participants asked to apply Ice chips to the oral mucosa for 5 min before the chemotherapy session and 20 min during session than 5 min after the session.
Artificial SalivaOther
The participants asked to use the artificial saliva for 7 days before breakfast, before lunch, before dinner and before bedtime. The patients given instructions on how to use the artificial saliva: they told to shake the bottle before use, to use enough artificial saliva to cover their whole mouth, to spray around their mouth, and to use their tongue to help spread the artificial saliva around their mouth.
| Study group | Role | What they receive |
|---|---|---|
| cold application | Experimental | The participants asked to apply Ice chips to the oral mucosa for 5 min before the chemotherapy session and 20 min during session than 5 min after the session. Receives: Other: cold application |
| artificial saliva | Experimental | The participants asked to use the artificial saliva for 7 days before breakfast, before lunch, before dinner and before bedtime. The participants given instructions on how to use the artificial saliva: they told to shake the bottle before use, to use enough artificial saliva to cover their whole mouth, to spray around their mouth, and to use their tongue to help spread the artificial saliva around their mouth. Receives: Other: Artificial Saliva |
| control group | No intervention | participants in the control group receive standard chemotherapy without cold application or artificial saliva |
What is being measured
The primary outcome is the main question the study is designed to answer.
Challacombe Scale of Clinical Oral Dryness
The Challacombe Scale is a clinician-administered tool for objectively assessing the severity of dry mouth (xerostomia) based on visual and tactile intraoral signs. It categorizes clinical oral dryness into ten grades (0 to 10), with increasing scores indicating greater severity. Key signs evaluated include mucosal appearance, saliva pooling, frothiness, and tongue features. This scale provides a standardized method to diagnose and monitor xerostomia
Measured: Baseline and Day 7
The World Health Organization (WHO) Oral Toxicity Scale
The World Health Organization Oral Toxicity Scale, which was developed by the World Health Organization (WHO) in 1979. This scale categorizes oral mucositis (OM), a condition that involves inflammation and ulceration of the mucous membranes lining the oral cavity, into five different grades based on the severity of symptoms and their impact on diet and oral intake.
Here is a brief overview of the five grades described in the scale. Grade 0: No Symptoms and diet is normal. Grade I: Soreness with or without erythematic (redness), and a solid diet is still possible.
Grade II: Erythema and Ulcers present, and a soft or liquid diet is possible. Grade III: Confluent Ulcerations with or without exudates (discharge), and the person can only consume liquids.
Grade IV: Deep Ulcerations and oral alimentation (consumption of food) is impossible. This grade is considered life-threatening.
Measured: Baseline and Day 7
Summated Xerostomia Inventory - SXI
The Summated Xerostomia Inventory (SXI) is a validated patient-reported outcome measure (PROM) used to quantify the subjective symptoms of dry mouth (xerostomia).It composed of five items each item is scored on a five-point scale. Scoring is as follows: a Never response is scored as 1; Hardly ever scores 2; Occasionally scores 3; Frequently scores 4; and always scores 5. The scores for the 5 items are summed to give an overall SXI score which can range from 5 to 25. A higher score indicates more severe symptoms of xerostomia.
Measured: Baseline and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion15 Feb 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cold application : Ice chips will be applied to the oral mucosa of the participants for 5 min before the chemotherapy session and 20 min during session than 5 min after the session. Artificial saliva: The patients will be asked to use the artificial saliva before breakfast, before lunch, before dinner and before bedtime. The patients will be given instructions on how to use the artificial saliva: they will be told to shake the bottle before use, to use enough artificial saliva to cover their whole mouth, to spray around their mouth, and to use their tongue to help spread the artificial saliva around their mouth.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karbala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Batool Abdulkareem Ahmed, Karbala University
- Investigators
- Batool A Ahmed, MSc, Principal investigator, kerbala heath department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297472
- Sponsor's protocol ID
- prevention oral mucositis
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cold Application and Artificial Saliva in the Prevention of Chemotherapy-Induced Oral Mucositis in Patients With Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07297472
- Acronym / sponsor ID
- prevention oral mucositis
- Conditions
- Oral Mucositis
- Keywords
- Cold application, Artificial saliva
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Karbala UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 22 Dec 2025 (actual)
- 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.
the Objectives of this clinical trial is :
- To determine the effect of Cold Application for preventing of chemotherapy-Induced oral mucositis in cancer patients.
- To examine the effect of artificial saliva for preventing of chemotherapy-Induced oral mucositis in cancer patients.
- To compare between the effect of artificial saliva and cold application for preventing of chemotherapy-Induced oral mucositis in cancer patients.
- To find out the differences between the effect of artificial saliva and cold application based on patient demographics and clinical data.
Detailed description
The non-keratinized mucosa of the oral cavity including the tongue, buccal mucosa, and lips is particularly susceptible to injury, leading to ulcerative lesions clinically known as oral mucositis (OM). This common and impactful toxicity of standard cancer therapy, characterized by mucosal damage that can range from mild inflammation to deep ulceration.
In cases CIOM, the severity often requires major clinical interventions, including diet modification, opioid analgesics, and nutritional supplementation, to avoid disrupting optimal cancer therapy. Furthermore, CIOM can lead to superinfection, with the additional threat of bacteremia and sepsis. Patients with OM are more likely to experience negative treatment outcomes , and higher healthcare costs compared to those without the condition.
Oral mucositis (OM) notably reduces quality of life by causing both physical and psychological distress. This condition can lead to serious psychological issues like anxiety, depression, and social isolation. Moreover, pre-existing anxiety and depression may serve as risk factors for the development of oral mucositis. (Borowski et al., 2025).
Although the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO) have recommended some strategies, our knowledge regarding the prevention and treatment of CIOM remains limited, with no established evidence-based management regimens. This underscores the need to develop novel therapeutic drugs and strategies .
Cold application, commonly described as the cooling of the mouth during chemotherapy. is a valuable tool for preventing OM in patients receiving certain chemotherapeutic agents. It is safe and well-tolerated, and it can help to reduce the risk of complications .
Patients undergoing chemotherapy often develop transient or permanent xerostomia (subjective symptom of dry mouth) and hyposalivation (objective reduction of salivary flow). Hyposalivation can elevate tissue inflammation and thus increase the risk of local infection and make mastication difficult.as a result increased risk of developing severe OM .
Artificial saliva works by forming a continuous, proactive, and hydrating film that helps prevent OM .Most clinical studies of artificial saliva only focused on signs and symptoms of dry mouth . However, the effect of artificial saliva on oral mucositis has not directly established yet.
While both interventions show individual promise, it is reasonable that their mechanisms of action are complementary. Cold application preventing the initial cytotoxic effect and artificial saliva protecting and healing the compromised mucosa. However, there are lack of the sufficient evidence evaluating their combined effect.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Cold application : Ice chips will be applied to the oral mucosa of the participants for 5 min before the chemotherapy session and 20 min during session than 5 min after the session. Artificial saliva: The patients will be asked to use the artificial saliva before breakfast, before lunch, before dinner and before bedtime. The patients will be given instructions on how to use the artificial saliva: they will be told to shake the bottle before use, to use enough artificial saliva to cover their whole mouth, to spray around their mouth, and to use their tongue to help spread the artificial saliva around their mouth.
| Arm | Type | Receives |
|---|---|---|
| cold application | Experimental | Other: cold applicationThe participants asked to apply Ice chips to the oral mucosa for 5 min before the chemotherapy session and 20 min during session than 5 min after the session. |
| artificial saliva | Experimental | Other: Artificial SalivaThe participants asked to use the artificial saliva for 7 days before breakfast, before lunch, before dinner and before bedtime. The participants given instructions on how to use the artificial saliva: they told to shake the bottle before use, to use enough artificial saliva to cover their whole mouth, to spray around their mouth, and to use their tongue to help spread the artificial saliva around their mouth. |
| control group | No intervention | –participants in the control group receive standard chemotherapy without cold application or artificial saliva |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who undergo chemotherapy.
- Patients who do not have oral mucositis.
- Patients who are aged 18 years and older.
- Patients who are male or female.
- Patients who agree to be included in the study sample.
Key exclusion criteria (5 listed)
- Patients who was refused to participate in the study.
- Patients who was not undergoing chemotherapy.
- Patients how was undergoing chemo-radiotherapy.
- Patients who selected for pilot study.
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 |
|---|---|---|
| cold applicationAlso: oral cryotherapyThe participants asked to apply Ice chips to the oral mucosa for 5 min before the chemotherapy session and 20 min during session than 5 min after the session. | Other | cold application |
| Artificial SalivaThe participants asked to use the artificial saliva for 7 days before breakfast, before lunch, before dinner and before bedtime. The patients given instructions on how to use the artificial saliva: they told to shake the bottle before use, to use enough artificial saliva to cover their whole mouth, to spray around their mouth, and to use their tongue to help spread the artificial saliva around their mouth. | Other | artificial saliva |
Primary outcome
Challacombe Scale of Clinical Oral Dryness
Time frame: Baseline and Day 7
The Challacombe Scale is a clinician-administered tool for objectively assessing the severity of dry mouth (xerostomia) based on visual and tactile intraoral signs. It categorizes clinical oral dryness into ten grades (0 to 10), with increasing scores indicating greater severity. Key signs evaluated include mucosal appearance, saliva pooling, frothiness, and tongue features. This scale provides a standardized method to diagnose and monitor xerostomia
The World Health Organization (WHO) Oral Toxicity Scale
Time frame: Baseline and Day 7
The World Health Organization Oral Toxicity Scale, which was developed by the World Health Organization (WHO) in 1979. This scale categorizes oral mucositis (OM), a condition that involves inflammation and ulceration of the mucous membranes lining the oral cavity, into five different grades based on the severity of symptoms and their impact on diet and oral intake. Here is a brief overview of the five grades described in the scale. Grade 0: No Symptoms and diet is normal. Grade I: Soreness with or without erythematic (redness), and a solid diet is still possible. Grade II: Erythema and Ulcers present, and a soft or liquid diet is possible. Grade III: Confluent Ulcerations with or without exudates (discharge), and the person can only consume liquids. Grade IV: Deep Ulcerations and oral alimentation (consumption of food) is impossible. This grade is considered life-threatening.
Summated Xerostomia Inventory - SXI
Time frame: Baseline and Day 7
The Summated Xerostomia Inventory (SXI) is a validated patient-reported outcome measure (PROM) used to quantify the subjective symptoms of dry mouth (xerostomia).It composed of five items each item is scored on a five-point scale. Scoring is as follows: a Never response is scored as 1; Hardly ever scores 2; Occasionally scores 3; Frequently scores 4; and always scores 5. The scores for the 5 items are summed to give an overall SXI score which can range from 5 to 25. A higher score indicates more severe symptoms of xerostomia.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Batool A Ahmed, MSc principal investigator
kerbala heath department
Questions about this trial
What is this clinical trial studying?
A study testing cold application and Artificial Saliva in people with Oral Mucositis, run by Karbala University.
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 5 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: opening soon, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Batool A Ahmed, MSc (+9647702871139, batool.abdulkareem@s.uokerbala.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Challacombe Scale of Clinical Oral Dryness (time frame: Baseline and Day 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Dec 2025.