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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorKarbala University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • cold application

    Other intervention

    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 Saliva

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: cold applicationExperimental treatment 1 intervention
Group B: artificial salivaExperimental treatment 1 intervention
Group C: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline and Day 7
2

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.

Time frame
Baseline and Day 7
3

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.

Time frame
Baseline and Day 7

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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