Cryotherapy vs Lidocaine Spray for Oral Mucositis

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.

Sex

All

Minimum age

18 Years

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).