Effect of Oral Ice Chips to Prevent Chemotherapy-Induced Oral Mucositis in Patient With Solid Tumor Treated With 5 Fluorouracil and Methotrexate

January 11, 2026 updated by: Aqsa Noor, University of Health Sciences Lahore

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:

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Sadam Nazir, MBA
  • Phone Number: 03004981203

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • University of Health Sciences
        • Contact:
          • Post Graduate Department, MS Nursing
          • Phone Number: 04299231075 04299231077
          • Email: info@uhs.edu.pk
        • Principal Investigator:
          • Aqsa Noor, MS nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Arm
Participants in control arm will use standard care as mouth wash only
Behavioral: Standard Oral Care (Mouthwash)
Participants will receive standard oral care using mouthwash (saline/bicarbonate/chlorhexidine) three times daily after chemotherapy at home.
Other Names:
  • Mouthwash
  • Standard Oral Care
Experimental: cryotherapy arm
Participant in experimental arm will use ice chips during chemotherapy infusion and standard care as mouth wash also.
Behavioral: Oral Cryotherapy (Ice Chips)
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.
Other Names:
  • Oral cryotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Health Sciences Lahore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

December 24, 2025

First Submitted That Met QC Criteria

December 24, 2025

First Posted (Estimated)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 11, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aqsa Noor

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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