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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-01

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Cold Application and Artificial Saliva in the Prevention of Chemotherapy-Induced Oral Mucositis

NCT07297472

Oral Mucositis

NOT_YET_RECRUITING NA

A Trial Assessing Chemo Mouthpiece Device With Best Supportive Care for Symptoms of Chemotherapy-Induced Oral Mucositis

NCT04595838

Oral Mucositis

COMPLETED NA

A Randomized Study to Establish the Efficacy of Oral Ice Exposure During Oxaliplatin Infusion in Preventing Oral Cold Sensitivity

NCT03427021

GI Patients on Oxaliplatin Containing Regimen

TERMINATED EARLY_PHASE1

Oral Cryotherapy to Decrease Taste Changes in Prostate Cancer Patients Receiving Taxane Chemotherapy

NCT07218718

Prostate Carcinoma

RECRUITING NA

The Impact of Oral Cryotherapy and Chewing Gum Interventions

NCT07145320

Breast Cancer Nausea and Vomiting Quality of Life +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chemotherapy Induced Oral Mucositis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Arm

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

Group Type ACTIVE_COMPARATOR

Standard Oral Care (Mouthwash)

Intervention Type BEHAVIORAL

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

cryotherapy arm

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

Group Type EXPERIMENTAL

Oral Cryotherapy (Ice Chips)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Standard Oral Care (Mouthwash)

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Oral cryotherapy Standard Oral Care Mouthwash

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No