Cryotherapy vs Lidocaine Spray for Oral Mucositis

NCT07727031 | Not Yet Recruiting DMC

• 1 other identifier: CON-2026-OM-001
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cancer

Keywords

Oral Mucositis; Cryotherapy; Oral Cryotherapy; Lidocaine Spray; Topical Lidocaine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Oral Intake Ability

  Throughout the chemotherapy treatment period (up to 14 days after chemotherapy).

• Analgesic Medication Requirement

  Throughout the chemotherapy treatment period (up to 14 days after chemotherapy).

• Treatment-Related Adverse Events

  From intervention initiation until 14 days after chemotherapy.

Study Arms (2)

Oral Cryotherapy

EXPERIMENTAL

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

Topical Lidocaine Spray

ACTIVE COMPARATOR

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

Interventions

Oral Cryotherapy OTHER

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.

Oral Cryotherapy

Topical Lidocaine Spray DRUG

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.

Topical Lidocaine Spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hanady Jabbar Mahmood: lead

MeSH Terms

Conditions

Neoplasms; Stomatitis

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Radhwan H Ibrahim, PhD

CONTACT

+9647722112891; prof.dr.radhwan@uomosul.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessment will be performed by a trained assessor who is blinded to treatment allocation. No other study personnel or participants are masked because the interventions (oral cryotherapy and topical lidocaine spray) are readily distinguishable during administration.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel intervention groups. One group will receive oral cryotherapy during chemotherapy administration, while the other group will receive topical lidocaine spray according to the study protocol. Outcomes will be assessed prospectively using standardized measures of oral mucositis severity and oral pain throughout the follow-up period. No crossover between groups will occur during the study.

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 27, 2026
• Study Start (Estimated): December 31, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 6 months after publication of the primary study results and continuing for 5 years after publication.
• 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.