Effect of Cold Application and Artificial Saliva in the Prevention of Chemotherapy-Induced Oral Mucositis

NCT07297472 | Not Yet Recruiting DMC

• 1 other identifier: prevention oral mucositis
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

the Objectives of this clinical trial is :

1. 1.To determine the effect of Cold Application for preventing of chemotherapy-Induced oral mucositis in cancer patients.
2. 2.To examine the effect of artificial saliva for preventing of chemotherapy-Induced oral mucositis in cancer patients.
3. 3.To compare between the effect of artificial saliva and cold application for preventing of chemotherapy-Induced oral mucositis in cancer patients.
4. 4.To find out the differences between the effect of artificial saliva and cold application based on patient demographics and clinical data.

Conditions

Oral Mucositis

Keywords

Cold application; Artificial saliva

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  Baseline and Day 7

Study Arms (3)

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.

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.

Other: Artificial Saliva

control group

NO INTERVENTION

participants in the control group receive standard chemotherapy without cold application or artificial saliva

Interventions

cold application OTHER

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.

Also known as: oral cryotherapy

cold application

Artificial Saliva OTHER

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.

artificial saliva

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karbala University: lead

MeSH Terms

Conditions

Stomatitis

Interventions

Cryotherapy; Saliva, Artificial

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Mouthwashes; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Batool A Ahmed, MSc

  kerbala heath department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Batool A Ahmed, MSc

CONTACT

+9647702871139; batool.abdulkareem@s.uokerbala.edu.iq

Hassan A Athbi, Assoc. Prof

CONTACT

+9647721902514; hasan.abdallh@uokerbala.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's graduate student

Model Details: 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.

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 22, 2025
• Study Start: January 1, 2026
• Primary Completion: February 15, 2026
• Study Completion: June 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share