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.
Inclusion Criteria:
Exclusion Criteria:
prof.dr.radhwan@uomosul.edu.iq+9647722112891
Outcome assessment will be performed by a trained assessor who is blinded to treatment allocation. No other study personnel or participants are masked because the interventions (oral cryotherapy and topical lidocaine spray) are readily distinguishable during administration.
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.
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.
Cryotherapy in the Prevention of Chemotherapy-Induced Mucositis in Stem Cell Transplant
Topical Chamomile in Preventing Chemotherapy-induced Oral Mucositis
A Trial Assessing Chemo Mouthpiece Device With Best Supportive Care for Symptoms of Chemotherapy-Induced Oral Mucositis
Comparative Trial of Cryotherapy Versus Caphosol Versus Saline Solution Mouth Washes for the Prevention of Oral Mucositis in Patients With Multiple Myeloma Undergoing Hematopoietic Stem Cell Transplantation
Effect of Oral Ice Chips to Prevent Chemotherapy-Induced Oral Mucositis in Patient With Solid Tumor Treated With 5 Fluorouracil and Methotrexate
The Efficacy of Oral Cryotherapy in Preventing TROP2-ADC-Induced Oral Mucositis in Patients With Advanced Breast Cancer
Prevention of Oral Mucositis After Using Chamomile Oral Cryotherapy Versus Oral Cryotherapy in Pediatric Cancer Patients Receiving Chemotherapy.
Cryotherapy for Prevention of Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation