An interventional study of Oral Cryotherapy and Topical Lidocaine Spray in Cancer, sponsored by Hanady Jabbar Mahmood. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Hanady Jabbar Mahmood · Not applicable, Interventional, and Supportive care
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.
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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 7,703 interventional studies indexed under Neoplasms.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Oral Cryotherapy
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.
Drug: Topical Lidocaine Spray
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.
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.
Severity of Chemotherapy-Induced Oral Mucositis
Severity of oral mucositis assessed using the World Health Organization (WHO) Oral Toxicity Scale (Grades 0-4). Higher grades indicate more severe oral mucositis.
Time frame: Baseline and throughout the chemotherapy treatment period (up to 14 days after chemotherapy).
Oral Pain Intensity
Oral pain assessed using the 11-point Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain).
Time frame: Baseline and throughout the chemotherapy treatment period (up to 14 days after chemotherapy).
Oral Intake Ability
Participants' ability to tolerate oral food and fluid intake during the study period, assessed using clinical evaluation and patient self-report.
Time frame: Throughout the chemotherapy treatment period (up to 14 days after chemotherapy).
Analgesic Medication Requirement
Requirement for additional analgesic medications to manage oral mucositis-related pain during the study period.
Time frame: Throughout the chemotherapy treatment period (up to 14 days after chemotherapy).
Treatment-Related Adverse Events
Incidence of adverse events associated with oral cryotherapy or topical lidocaine spray.
Time frame: From intervention initiation until 14 days after chemotherapy.
No study locations are listed for this record.
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Beginning 6 months after publication of the primary study results and continuing for 5 years after publication.
Access criteria: De-identified individual participant data, the study protocol, statistical analysis plan, and data dictionary will be made available to qualified researchers who submit a methodologically sound research proposal. Requests should be directed to the Principal Investigator. Access will be granted after review and approval by the study investigators and, where applicable, the institutional ethics committee. A data use agreement may be required before data are released.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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