Chemotherapy Induced Oral MucositisNCT07327476
Effect of Oral Ice Chips to Prevent Chemotherapy-Induced Oral Mucositis in Patient With Solid Tumor Treated With 5 Fluorouracil and Methotrexate
A study testing Oral Cryotherapy (Ice Chips) and Standard Oral Care (Mouthwash) in people with Chemotherapy Induced Oral Mucositis, run by University of Health Sciences Lahore at 1 site in Pakistan.
Trial summary
The goal of this randomized controlled clinical trial is to determine whether oral cryotherapy using ice chips can prevent and reduce the incidence and severity of chemotherapy-induced oral mucositis in adult cancer patients receiving 5-fluorouracil and methotrexate chemotherapy regimens. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chemotherapy Induced Oral Mucositis
- What is being tested?
- Oral Cryotherapy (Ice Chips) and Standard Oral Care (Mouthwash)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2026to 30 Nov 2026
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-60 years.
- Patients treated with 5-Fluorouracil and Methotrexate regimens.
- Patients scheduled for a two-week cycle of chemotherapy.
- Patients able to tolerate ice and able to communicate effectively.
Who cannot join
- Patients with diabetes mellitus, cardiovascular disorders, or any immune- compromised disease.
- Patients with head and neck surgeries, oral or pharyngeal cancer, or any problems in the oral cavity.
- Patients currently enrolled in or who have signed consent for any other clinical studies that could interfere with the desired outcomes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sadam Nazir, MBA contact
Pakistan1 site
University of Health Sciences
Lahore, Punjab Province, 54000
Post Graduate Department, MS Nursing, 04299231077 ext. 04299231075, info@uhs.edu.pk
Aqsa Noor, MS nursing
About this study
Official title: Effects Of Oral Ice Chips On Prevention of Chemotherapy Induced Oral Mucositis In Patients With Solid Tumors Treated With 5 Fluorouracil and Methotrexate In Tertiary Care Hospital , Lahore: A Randomize Control Trial
The goal of this randomized controlled clinical trial is to determine whether oral cryotherapy using ice chips can prevent and reduce the incidence and severity of chemotherapy-induced oral mucositis in adult cancer patients receiving 5-fluorouracil and methotrexate chemotherapy regimens.
The main questions it aims to answer are:
Read more
Does the application of oral ice chips reduce the severity of oral mucositis compared to routine mouth care alone?
Is there a significant difference in oral mucositis grades between patients receiving oral cryotherapy and those receiving standard mouthwash care?
Researchers will compare the experimental group receiving oral ice chips during chemotherapy plus routine mouthwash care with the control group receiving routine mouthwash care only to evaluate the effectiveness of oral cryotherapy in reducing oral mucositis severity.
Participants will:
Be randomly assigned to either the experimental group (n = 51) or control group (n = 51)
Receive chemotherapy with 5-fluorouracil or methotrexate
Use routine mouthwash (normal saline/sodium bicarbonate/chlorhexidine) at home
Receive oral ice chips during chemotherapy infusion (experimental group only)
Be assessed for oral mucositis severity using the WHO Oral Mucositis Grading Scale before and after the intervention
Read the detailed description
Chemotherapy-induced oral mucositis is a common and serious side effect among cancer patients receiving chemotherapy. It causes pain, difficulties in eating and speaking, a greater risk of infection, bleeding, distress, and an overall lower quality of life. According to WHO the prevalence of mucositis after chemotherapy is between 20% and 40% of cancer patients receiving standard chemotherapy treatments, with higher rates seen in patients undergoing high- dose chemotherapy where the incidence can reach up to 80%. The goal of oral cryotherapy is to apply local cooling to the tissue of oral mucosa to prevent and minimize the incidence and severity of oral mucositis. This study aim is to assess the level of oral mucositis (OM) among cancer patients who receive chemotherapy before and after the application of oral ice cubes. This study will be conducted by using randomize control design. Patient who are receiving chemotherapy with 5-fluorouracil regimens and methotrexate regimens will be considered as population of this study. Non Probability purposive sampling will be used. Total sample of 102 patients will be taken than randomly assign to experimental group(n=51) and control group(n=51). Ice chips will be applied in the oral cavity of experimental group during chemotherapy and mouth wash (normal saline/sodium bicarbonate/chlorhexidine) use in home. Control group will use only mouth wash(normal saline/sodium bicarbonate/chlorhexidine). The severity of oral mucositis will be assess by using WHO oral mucositis grading scale. All collected information will be analyzed through SPSS version 27. The study will utilize descriptive statistics(mean,standard deviation,frequency and percentage) to analyze the demographic characteristics of the sample. To compare mucositis scores between the experimental and control groups the chi-square test will be used. A significance level of p < 0.05 will be considered statistically significant.The findings of current study will guide the nursing practice to improve and may be significant for cancer patients. The findings can support evidence-based nursing care by incorporating ice chips as a simple, cost-effective, and non- pharmacological intervention in oncology settings. Effective use of ice chips may decrease the need for analgesics and topical treatments, reducing potential side effects and healthcare costs. By minimizing pain and discomfort, the intervention may enhance nutritional intake, oral hygiene, and overall quality of life for chemotherapy patients.
- Conditions
- Chemotherapy Induced Oral Mucositis
- Being tested
- Oral Cryotherapy (Ice Chips), Standard Oral Care (Mouthwash)
- Keywords
- Cryotherapy, Solid tumor, oral mucositis
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Cryotherapy (Ice Chips)Behavioural
Also called Oral cryotherapy
For participants in the experimental group will undergone cryotherapy in the form of oral ice chips. Oral ice chips will be applied in oral cavity of patients by the researcher as followings: 5 minutes before chemotherapy session, participants will begin sucking on ice chips. During chemotherapy, ice chips will be continuously sucked for 5 minutes, followed by a 5-minutes break, after that this process repeated for another 5minutes total time of application of ice is 30 minutes.
Standard Oral Care (Mouthwash)Behavioural
Also called Standard Oral Care, Mouthwash
Participants will receive standard oral care using mouthwash (saline/bicarbonate/chlorhexidine) three times daily after chemotherapy at home.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | Participants in control arm will use standard care as mouth wash only Receives: Behavioral: Standard Oral Care (Mouthwash) |
| cryotherapy arm | Experimental | Participant in experimental arm will use ice chips during chemotherapy infusion and standard care as mouth wash also. Receives: Behavioral: Oral Cryotherapy (Ice Chips) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of chemotherapy-induced oral mucositis
The severity of chemotherapy-induced oral mucositis will be assessed using the World Health Organization (WHO) Oral Mucositis Grading Scale. The scale ranges from Grade 0 to Grade 4, where Grade 0 = no oral mucositis, Grade 1 = soreness/erythema, Grade 2 = ulcers but able to eat solid food, Grade 3 = ulcers with liquid diet only, and Grade 4 = severe ulcers requiring enteral or parenteral nutrition. Higher scores indicate more severe oral mucositis.
Measured: Both groups will be assessed for the development and severity of oral mucositis on day 7 and day 14 after chemotherapy using the WHO Oral Mucositis Grading Scale.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start15 Jul 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy Induced Oral MucositisStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control Group (mouth wash only) Intervention Group (Oral ice chips + mouth wash)
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aqsa Noor, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327476
- Sponsor's protocol ID
- Aqsa Noor
- Status last verified
- Jun 2026
- First submitted
- 24 Dec 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Oral Ice Chips On Prevention of Chemotherapy Induced Oral Mucositis In Patients With Solid Tumors Treated With 5 Fluorouracil and Methotrexate In Tertiary Care Hospital , Lahore: A Randomize Control Trial
- ClinicalTrials.gov ID
- NCT07327476
- Acronym / sponsor ID
- Aqsa Noor
- Conditions
- Chemotherapy Induced Oral Mucositis
- Keywords
- Cryotherapy, Solid tumor, oral mucositis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 8 Jan 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 randomized controlled clinical trial is to determine whether oral cryotherapy using ice chips can prevent and reduce the incidence and severity of chemotherapy-induced oral mucositis in adult cancer patients receiving 5-fluorouracil and methotrexate chemotherapy regimens.
The main questions it aims to answer are:
Does the application of oral ice chips reduce the severity of oral mucositis compared to routine mouth care alone?
Is there a significant difference in oral mucositis grades between patients receiving oral cryotherapy and those receiving standard mouthwash care?
Researchers will compare the experimental group receiving oral ice chips during chemotherapy plus routine mouthwash care with the control group receiving routine mouthwash care only to evaluate the effectiveness of oral cryotherapy in reducing oral mucositis severity.
Participants will:
Be randomly assigned to either the experimental group (n = 51) or control group (n = 51)
Receive chemotherapy with 5-fluorouracil or methotrexate
Use routine mouthwash (normal saline/sodium bicarbonate/chlorhexidine) at home
Receive oral ice chips during chemotherapy infusion (experimental group only)
Be assessed for oral mucositis severity using the WHO Oral Mucositis Grading Scale before and after the intervention
Detailed description
Chemotherapy-induced oral mucositis is a common and serious side effect among cancer patients receiving chemotherapy. It causes pain, difficulties in eating and speaking, a greater risk of infection, bleeding, distress, and an overall lower quality of life. According to WHO the prevalence of mucositis after chemotherapy is between 20% and 40% of cancer patients receiving standard chemotherapy treatments, with higher rates seen in patients undergoing high- dose chemotherapy where the incidence can reach up to 80%. The goal of oral cryotherapy is to apply local cooling to the tissue of oral mucosa to prevent and minimize the incidence and severity of oral mucositis. This study aim is to assess the level of oral mucositis (OM) among cancer patients who receive chemotherapy before and after the application of oral ice cubes. This study will be conducted by using randomize control design. Patient who are receiving chemotherapy with 5-fluorouracil regimens and methotrexate regimens will be considered as population of this study. Non Probability purposive sampling will be used. Total sample of 102 patients will be taken than randomly assign to experimental group(n=51) and control group(n=51). Ice chips will be applied in the oral cavity of experimental group during chemotherapy and mouth wash (normal saline/sodium bicarbonate/chlorhexidine) use in home. Control group will use only mouth wash(normal saline/sodium bicarbonate/chlorhexidine). The severity of oral mucositis will be assess by using WHO oral mucositis grading scale. All collected information will be analyzed through SPSS version 27. The study will utilize descriptive statistics(mean,standard deviation,frequency and percentage) to analyze the demographic characteristics of the sample. To compare mucositis scores between the experimental and control groups the chi-square test will be used. A significance level of p < 0.05 will be considered statistically significant.The findings of current study will guide the nursing practice to improve and may be significant for cancer patients. The findings can support evidence-based nursing care by incorporating ice chips as a simple, cost-effective, and non- pharmacological intervention in oncology settings. Effective use of ice chips may decrease the need for analgesics and topical treatments, reducing potential side effects and healthcare costs. By minimizing pain and discomfort, the intervention may enhance nutritional intake, oral hygiene, and overall quality of life for chemotherapy patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Control Group (mouth wash only) Intervention Group (Oral ice chips + mouth wash)
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Behavioral: Standard Oral Care (Mouthwash)Participants in control arm will use standard care as mouth wash only |
| cryotherapy arm | Experimental | Behavioral: Oral Cryotherapy (Ice Chips)Participant in experimental arm will use ice chips during chemotherapy infusion and standard care as mouth wash also. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults aged 18-60 years.
- Patients treated with 5-Fluorouracil and Methotrexate regimens.
- Patients scheduled for a two-week cycle of chemotherapy.
- Patients able to tolerate ice and able to communicate effectively.
Key exclusion criteria (3 listed)
- Patients with diabetes mellitus, cardiovascular disorders, or any immune- compromised disease.
- Patients with head and neck surgeries, oral or pharyngeal cancer, or any problems in the oral cavity.
- Patients currently enrolled in or who have signed consent for any other clinical studies that could interfere with the desired outcomes.
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 Cryotherapy (Ice Chips)Also: Oral cryotherapyFor participants in the experimental group will undergone cryotherapy in the form of oral ice chips. Oral ice chips will be applied in oral cavity of patients by the researcher as followings: 5 minutes before chemotherapy session, participants will begin sucking on ice chips. During chemotherapy, ice chips will be continuously sucked for 5 minutes, followed by a 5-minutes break, after that this process repeated for another 5minutes total time of application of ice is 30 minutes. | Behavioural | cryotherapy arm |
| Standard Oral Care (Mouthwash)Also: Standard Oral Care, MouthwashParticipants will receive standard oral care using mouthwash (saline/bicarbonate/chlorhexidine) three times daily after chemotherapy at home. | Behavioural | Control Arm |
Primary outcome
Severity of chemotherapy-induced oral mucositis
Time frame: Both groups will be assessed for the development and severity of oral mucositis on day 7 and day 14 after chemotherapy using the WHO Oral Mucositis Grading Scale.
The severity of chemotherapy-induced oral mucositis will be assessed using the World Health Organization (WHO) Oral Mucositis Grading Scale. The scale ranges from Grade 0 to Grade 4, where Grade 0 = no oral mucositis, Grade 1 = soreness/erythema, Grade 2 = ulcers but able to eat solid food, Grade 3 = ulcers with liquid diet only, and Grade 4 = severe ulcers requiring enteral or parenteral nutrition. Higher scores indicate more severe oral mucositis.
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 16 Jun 2026.
- Article: Oral mucositis \& oral health related quality of life in women undergoing chemotherapy for breast cancer in Karachi, Pakistan: A multicenter hospital based cross-sectional studyLink provided by the sponsor.
- Article: The Effects of Oral Cryotherapy on Chemotherapy-Induced Oral Mucositis in Patients Undergoing Autologous Transplantation of Blood Stem Cells: A Clinical TrialLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Sadam Nazir, MBA contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Cryotherapy (Ice Chips) and Standard Oral Care (Mouthwash) in people with Chemotherapy Induced Oral Mucositis, run by University of Health Sciences Lahore at 1 site in Pakistan.
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 4 inclusion and 3 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 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Aqsa Noor, MS Nursing (03044548726, aqsanoor448@gmail.com), 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: Both groups will be assessed for the development and severity of oral mucositis on day 7 and day 14 after chemotherapy using the WHO Oral Mucositis Grading Scale.). 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 16 Jun 2026.