CancerCryotherapy vsNCT07727031
Cryotherapy vs Lidocaine Spray for Oral Mucositis
A study testing Oral Cryotherapy and Topical Lidocaine Spray in people with Cancer, run by Hanady Jabbar Mahmood.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Oral Cryotherapy and Topical Lidocaine Spray
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Cryotherapy Versus Lidocaine Spray for the Management of Chemotherapy-Induced Oral Mucositis: A Randomized Controlled Trial
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:
Read more
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Oral Cryotherapy, Topical Lidocaine Spray
- Keywords
- Oral Mucositis, Cryotherapy, Oral Cryotherapy, Lidocaine Spray, Topical Lidocaine
- Medical subject headings
- Neoplasms, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral CryotherapyOther
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.
Topical Lidocaine SprayDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral Cryotherapy | Experimental | 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. Receives: Other: Oral Cryotherapy |
| Topical Lidocaine Spray | Active comparator | 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. Receives: Drug: Topical Lidocaine Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Baseline and throughout the chemotherapy treatment period (up to 14 days after chemotherapy).
Secondary outcomes (3)
Oral Intake Ability
Participants' ability to tolerate oral food and fluid intake during the study period, assessed using clinical evaluation and patient self-report.
Measured: 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.
Measured: 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.
Measured: From intervention initiation until 14 days after chemotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start31 Dec 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanady Jabbar Mahmood
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hanady Jabbar Mahmood, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727031
- Sponsor's protocol ID
- CON-2026-OM-001
- Acronym
- Cryotherapy vs
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryotherapy Versus Lidocaine Spray for the Management of Chemotherapy-Induced Oral Mucositis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07727031
- Acronym / sponsor ID
- Cryotherapy vs / CON-2026-OM-001
- Conditions
- Cancer
- Keywords
- Oral Mucositis, Cryotherapy, Oral Cryotherapy, Lidocaine Spray, Topical Lidocaine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hanady Jabbar MahmoodUniversity, hospital or other
- Study start
- 31 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Oral Cryotherapy | Experimental | Other: Oral CryotherapyParticipants 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. |
| Topical Lidocaine Spray | Active comparator | Drug: Topical Lidocaine SprayParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral CryotherapyParticipants 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. | Other | Oral Cryotherapy |
| Topical Lidocaine SprayParticipants 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. | Drug | Topical Lidocaine Spray |
Primary outcome
Severity of Chemotherapy-Induced Oral Mucositis
Time frame: 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
Time frame: 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).
3 secondary outcomes
Oral Intake Ability
Time frame: Throughout the chemotherapy treatment period (up to 14 days after chemotherapy).
Analgesic Medication Requirement
Time frame: Throughout the chemotherapy treatment period (up to 14 days after chemotherapy).
Treatment-Related Adverse Events
Time frame: From intervention initiation until 14 days after chemotherapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Cryotherapy and Topical Lidocaine Spray in people with Cancer, run by Hanady Jabbar Mahmood.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Radhwan H Ibrahim, PhD (+9647722112891, prof.dr.radhwan@uomosul.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Chemotherapy-Induced Oral Mucositis (time frame: Baseline and throughout the chemotherapy treatment period (up to 14 days after chemotherapy).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.