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

NCT07327476 | Not Yet Recruiting DMC

• 1 other identifier: Aqsa Noor
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Chemotherapy Induced Oral Mucositis

Keywords

Cryotherapy; Solid tumor; oral mucositis

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

Participants in control arm will use standard care as mouth wash only

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.

Behavioral: Oral Cryotherapy (Ice Chips)

Interventions

Standard Oral Care (Mouthwash) BEHAVIORAL

Participants will receive standard oral care using mouthwash (saline/bicarbonate/chlorhexidine) three times daily after chemotherapy at home.

Also known as: Standard Oral Care, Mouthwash

Control Arm

Oral Cryotherapy (Ice Chips) BEHAVIORAL

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.

Also known as: Oral cryotherapy

cryotherapy arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

Study Sites (1)

University of Health Sciences

Lahore, Punjab Province, 54000, Pakistan

Location

Related Links

• Article: Effect of Ice Chips on Severity of Chemotherapy Induced Oral Mucositis
• 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 study
• Article: The Effects of Oral Cryotherapy on Chemotherapy-Induced Oral Mucositis in Patients Undergoing Autologous Transplantation of Blood Stem Cells: A Clinical Trial

MeSH Terms

Conditions

Stomatitis

Interventions

Cryotherapy; Mouthwashes

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Aqsa Noor, MS Nursing

CONTACT

03044548726; aqsanoor448@gmail.com

Sadam Nazir, MBA

CONTACT

03004981203

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MS Nursing Student

Model Details: Control Group (mouth wash only) Intervention Group (Oral ice chips + mouth wash)

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 8, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)