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
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.
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.
Parallel
Oral Cryotherapy (Ice Chips)
BehavioralFor 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)
BehavioralParticipants will receive standard oral care using mouthwash (saline/bicarbonate/chlorhexidine) three times daily after chemotherapy at home.
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.
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