Cryotherapy vs Lidocaine Spray for Oral Mucositis (Cryotherapy vs)

Cryotherapy Versus Lidocaine Spray for the Management of Chemotherapy-Induced Oral Mucositis: A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: Oral Cryotherapy; Drug: Topical Lidocaine Spray

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Radhwan H Ibrahim, PhD; Phone Number: +9647722112891; Email: prof.dr.radhwan@uomosul.edu.iq

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Cryotherapy; Participants assigned to this arm will receive oral cryotherapy using ice chips. Cryotherapy will begin approximately 5 minutes before chemotherapy infusion and continue for about 30 minutes during chemotherapy administration under nursing supervision.	Other: 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.
Active Comparator: Topical Lidocaine Spray; Participants assigned to this arm will receive 10% topical lidocaine spray before chemotherapy administration according to the study protocol and approved product instructions. Additional doses may be provided as clinically required within the permitted dosing schedule.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of Chemotherapy-Induced Oral Mucositis	Severity of oral mucositis assessed using the World Health Organization (WHO) Oral Toxicity Scale (Grades 0-4). Higher grades indicate more severe oral mucositis.	Baseline and throughout the chemotherapy treatment period (up to 14 days after chemotherapy).
Oral Pain Intensity	Oral pain assessed using the 11-point Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain).	Baseline and throughout the chemotherapy treatment period (up to 14 days after chemotherapy).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral Intake Ability	Participants' ability to tolerate oral food and fluid intake during the study period, assessed using clinical evaluation and patient self-report.	Throughout the chemotherapy treatment period (up to 14 days after chemotherapy).
Analgesic Medication Requirement	Requirement for additional analgesic medications to manage oral mucositis-related pain during the study period.	Throughout the chemotherapy treatment period (up to 14 days after chemotherapy).
Treatment-Related Adverse Events	Incidence of adverse events associated with oral cryotherapy or topical lidocaine spray.	From intervention initiation until 14 days after chemotherapy.

Collaborators and Investigators

• Sponsor: Hanady Jabbar Mahmood

Study record dates

Study Major Dates

• Study Start (Estimated): December 31, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 24, 2026
• First Posted (Actual): July 27, 2026

Study Record Updates

• Last Update Posted (Actual): July 27, 2026
• Last Update Submitted That Met QC Criteria: July 24, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Cryotherapy; Oral Mucositis; Topical Lidocaine; Oral Cryotherapy; Lidocaine Spray
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Neoplasms; Stomatitis; Therapeutics; Cryotherapy
• Other Study ID Numbers: CON-2026-OM-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Beginning 6 months after publication of the primary study results and continuing for 5 years after publication.
• IPD Sharing Access Criteria: De-identified individual participant data, the study protocol, statistical analysis plan, and data dictionary will be made available to qualified researchers who submit a methodologically sound research proposal. Requests should be directed to the Principal Investigator. Access will be granted after review and approval by the study investigators and, where applicable, the institutional ethics committee. A data use agreement may be required before data are released.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No