An interventional study of Oral Cryotherapy (Ice Chips) and Standard Oral Care (Mouthwash) in Chemotherapy Induced Oral Mucositis, sponsored by University of Health Sciences Lahore. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by University of Health Sciences Lahore · Not applicable, Interventional, and Prevention
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
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.
306 studies on the registry are indexed under Stomatitis; 75 are open to participants now.
This study's planned enrollment of 102 is above the median of 60 across 276 interventional studies indexed under Stomatitis.
Browse Stomatitis studies →University of Health Sciences Lahore is the lead sponsor of 83 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Participants in control arm will use standard care as mouth wash only
Behavioral: Standard Oral Care (Mouthwash)
Participant in experimental arm will use ice chips during chemotherapy infusion and standard care as mouth wash also.
Behavioral: 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.
Also known as: Oral cryotherapy
Participants will receive standard oral care using mouthwash (saline/bicarbonate/chlorhexidine) three times daily after chemotherapy at home.
Also known as: Standard Oral Care, Mouthwash
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.
Time frame: Both groups will be assessed for the development and severity of oral mucositis on day 7 and day 14 after chemotherapy using the WHO Oral Mucositis Grading Scale.
Plan to share: No
Start is estimated for Jul 2026; primary completion for Oct 2026, 3 months later.
Of 65 non-industry interventional studies with no phase under Stomatitis, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 57. This study's planned 3 months is below that.
Counting every sponsor, half of 73 studies reached it within 14 months; a quarter within 10 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Health Sciences Lahore