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Cryotherapy vs Lidocaine Spray for Oral Mucositis

NCT07727031 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-07-27

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Hanady Jabbar Mahmood

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2026-12-31
Completion
2027-01-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07727031 on ClinicalTrials.gov