Cryotherapy vs Lidocaine Spray for Oral Mucositis

Chemotherapy-induced oral mucositis (CIOM) is one of the most common and debilitating adverse effects of cancer treatment. It can cause severe oral pain, difficulty eating and swallowing, impaired quality of life, treatment interruptions, and increased healthcare utilization. Effective supportive care interventions are therefore essential to minimize the burden of oral mucositis and maintain adherence to chemotherapy.

Oral cryotherapy is recommended for selected chemotherapy regimens because local cooling of the oral mucosa reduces blood flow during drug infusion, thereby limiting exposure of oral tissues to cytotoxic agents. Topical lidocaine spray is commonly used to relieve oral pain associated with mucositis but does not prevent tissue injury. Although both interventions are used in clinical practice, evidence directly comparing their effectiveness remains limited.

This study is a prospective, parallel-group, randomized controlled trial designed to compare oral cryotherapy with topical lidocaine spray in adult patients receiving chemotherapy. Eligible participants will be randomly allocated in a 1:1 ratio to receive either oral cryotherapy or topical lidocaine spray during chemotherapy administration according to the study protocol.

The primary outcomes are the severity of oral mucositis, assessed using the World Health Organization (WHO) Oral Toxicity Scale, and oral pain intensity, measured using the Numeric Rating Scale (NRS). Outcome assessments will be performed at predefined follow-up time points by trained assessors using standardized evaluation procedures.

The findings of this study are expected to provide high-quality evidence regarding the comparative effectiveness of oral cryotherapy and topical lidocaine spray for the prevention and management of chemotherapy-induced oral mucositis. The results may help inform supportive care practices and contribute to improving symptom control and quality of life among patients undergoing chemotherapy.

Inclusion criteria

• Adults aged 18 years or older.
• Histologically or cytologically confirmed diagnosis of cancer.
• Scheduled to receive chemotherapy associated with a moderate or high risk of oral mucositis.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Able to understand the study procedures and provide written informed consent.
• Willing to comply with all study procedures and follow-up assessments.

Exclusion criteria

• Receiving concurrent head and neck radiotherapy.
• Presence of severe pre-existing oral disease or active oral infection that may interfere with outcome assessment.
• Known hypersensitivity or contraindication to lidocaine or its components.
• Medical contraindication or intolerance to oral cryotherapy (e.g., cold hypersensitivity, cryoglobulinemia, or cold agglutinin disease).
• Cognitive impairment or psychiatric illness preventing informed consent or study participation.
• Participation in another interventional clinical trial for the prevention or treatment of oral mucositis during the study period.
• Pregnant or breastfeeding women (if specified as ineligible in the study protocol).