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

Karbala University

Status: Not yet enrolling

Conditions: Oral Mucositis

Treatments: Other: Artificial Saliva; Other: cold application

Study type: Interventional

Funder types: Other

Identifiers

NCT07297472

prevention oral mucositis

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

cold application

Experimental group

Description:

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.

Treatment:

Other: cold application

artificial saliva

Experimental group

Description:

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.

Treatment:

Other: Artificial Saliva

control group

No Intervention group

Description:

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