Cryotherapy vs Lidocaine Spray for Oral Mucositis

Official title

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

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.

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.

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.

Primary outcome measures

• Severity of Chemotherapy-Induced Oral Mucositis [Time frame: Baseline and throughout the chemotherapy treatment period (up to 14 days after chemotherapy).]
• Oral Pain Intensity [Time frame: Baseline and throughout the chemotherapy treatment period (up to 14 days after chemotherapy).]

Secondary outcome measures (3)

• Oral Intake Ability [Time frame: Throughout the chemotherapy treatment period (up to 14 days after chemotherapy).]
• Analgesic Medication Requirement [Time frame: Throughout the chemotherapy treatment period (up to 14 days after chemotherapy).]
• Treatment-Related Adverse Events [Time frame: From intervention initiation until 14 days after chemotherapy.]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07727031 · CON-2026-OM-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗