Cryotherapy vs Lidocaine Spray for Oral Mucositis (NCT07727031) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Cryotherapy vs Lidocaine Spray for Oral Mucositis
60 participantsStarted 2026-12-31
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Severity of Chemotherapy-Induced Oral Mucositis
Timeframe: Baseline and throughout the chemotherapy treatment period (up to 14 days after chemotherapy).
2
Oral Pain Intensity
Timeframe: Baseline and throughout the chemotherapy treatment period (up to 14 days after chemotherapy).