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

Starting soon · Not applicable

Conditions studied: Chemotherapy Induced Oral Mucositis

In brief

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

Key facts

Study ID

NCT07327476

Run by

University of Health Sciences Lahore

People needed

102

Starts

2026-07-15

Expected to finish

2026-11-30

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• University of Health Sciences — Lahore, Punjab Province, Pakistan

Full record on ClinicalTrials.gov

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