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

University of Health Sciences Lahore

Status: Begins enrollment this month

Conditions: Chemotherapy Induced Oral Mucositis

Treatments: Behavioral: Oral Cryotherapy (Ice Chips); Behavioral: Standard Oral Care (Mouthwash)

Study type: Interventional

Funder types: Other

Identifiers

NCT07327476

Aqsa Noor

Details and patient eligibility

About

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

Full 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.

Enrollment: 102 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Control Arm

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard Oral Care (Mouthwash)

cryotherapy arm

Experimental group

Description:

Participant in experimental arm will use ice chips during chemotherapy infusion and standard care as mouth wash also.

Treatment:

Behavioral: Oral Cryotherapy (Ice Chips)