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Effect of Oral Ice Chips to Prevent Chemotherapy-Induced Oral Mucositis in Patient With Solid Tumor Treated With 5 Fluorouracil and Methotrexate
Sponsor: University of Health Sciences Lahore
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
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
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
102
Start Date
2026-03-01
Completion Date
2026-09-30
Last Updated
2026-01-13
Healthy Volunteers
No
Conditions
Interventions
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.
Standard Oral Care (Mouthwash)
Participants will receive standard oral care using mouthwash (saline/bicarbonate/chlorhexidine) three times daily after chemotherapy at home.
Locations (1)
University of Health Sciences
Lahore, Punjab Province, Pakistan