Cancer
Conditions
Keywords
Oral Mucositis, Cryotherapy, Oral Cryotherapy, Lidocaine Spray, Topical Lidocaine
Brief 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.
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
OTHEROral 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.
DRUGTopical 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.
Sponsors
Hanady Jabbar Mahmood
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to one of two parallel intervention groups. One group will receive oral cryotherapy during chemotherapy administration, while the other group will receive topical lidocaine spray according to the study protocol. Outcomes will be assessed prospectively using standardized measures of oral mucositis severity and oral pain throughout the follow-up period. No crossover between groups will occur during the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Chemotherapy-Induced Oral Mucositis | Baseline and throughout the chemotherapy treatment period (up to 14 days after chemotherapy). | Severity of oral mucositis assessed using the World Health Organization (WHO) Oral Toxicity Scale (Grades 0-4). Higher grades indicate more severe oral mucositis. |
| Oral Pain Intensity | Baseline and throughout the chemotherapy treatment period (up to 14 days after chemotherapy). | Oral pain assessed using the 11-point Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oral Intake Ability | Throughout the chemotherapy treatment period (up to 14 days after chemotherapy). | Participants' ability to tolerate oral food and fluid intake during the study period, assessed using clinical evaluation and patient self-report. |
| Analgesic Medication Requirement | Throughout the chemotherapy treatment period (up to 14 days after chemotherapy). | Requirement for additional analgesic medications to manage oral mucositis-related pain during the study period. |
| Treatment-Related Adverse Events | From intervention initiation until 14 days after chemotherapy. | Incidence of adverse events associated with oral cryotherapy or topical lidocaine spray. |
Contacts
CONTACTRadhwan H Ibrahim, PhD
Outcome results
None listed