Cryotherapy vs Lidocaine Spray for Oral Mucositis

Overview

The goal of this clinical trial is to evaluate the effectiveness of oral cryotherapy compared with topical lidocaine spray in preventing and reducing the severity of chemotherapy-induced oral mucositis among adult patients with cancer receiving chemotherapy. It will also assess the impact of these interventions on oral pain and treatment tolerability. The main questions it aims to answer are: Does oral cryotherapy reduce the severity of chemotherapy-induced oral mucositis more effectively than topical lidocaine spray? Does oral cryotherapy reduce oral pain more effectively than topical lidocaine spray? Researchers will compare oral cryotherapy with topical lidocaine spray to determine which intervention provides better prevention and management of chemotherapy-induced oral mucositis. Participants will: Be randomly assigned to receive either oral cryotherapy or topical lidocaine spray during chemotherapy. Undergo regular assessments of oral mucositis severity using the World Health Organization (WHO) Oral Toxicity Scale. Report oral pain using a Numeric Rating Scale (NRS) at scheduled follow-up visits. Complete all study assessments during the chemotherapy treatment period to evaluate treatment effectiveness and safety.

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.