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Cryotherapy vs Lidocaine Spray for Oral Mucositis
Sponsor: Hanady Jabbar Mahmood
Summary
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.
Official title: Cryotherapy Versus Lidocaine Spray for the Management of Chemotherapy-Induced Oral Mucositis: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-12-31
Completion Date
2027-01-31
Last Updated
2026-07-27
Healthy Volunteers
No
Conditions
Interventions
Oral Cryotherapy
Participants will receive oral cryotherapy using ice chips. Cryotherapy will begin approximately 5 minutes before chemotherapy infusion and continue for 30 minutes during the infusion under nursing supervision. Participants will be instructed to move the ice chips around the oral cavity and replace them as they melt.
Topical Lidocaine Spray
Participants will receive 10% topical lidocaine spray applied to the oral mucosa before chemotherapy administration according to the study protocol and product instructions. Repeat administration may be provided when clinically required within the recommended dosing limits.