Cryotherapy vs Lidocaine Spray for Oral Mucositis

Sponsor
Hanady Jabbar Mahmood
Study ID
NCT07727031
Status
Not Yet Recruiting

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Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Jul 27, 2026
Start date
Dec 31, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.
  • 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.

Primary Outcome Measure

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

Central Contacts

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