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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

NCT07327476 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-01-13

No results posted yet for this study

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

Conditions

  • Chemotherapy Induced Oral Mucositis

Interventions

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.

BEHAVIORAL

Standard Oral Care (Mouthwash)

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

Sponsors & Collaborators

  • University of Health Sciences Lahore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2026-08-30
Completion
2026-09-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07327476 on ClinicalTrials.gov