Construction and Preliminary Application of Evidence-Based Nursing Protocol for Oral Mucositis Related to Tumor Therapy

December 12, 2025 updated by: Yutong XU, Peking Union Medical College
Describe the incidence and influencing factors of cancer therapy-related oral mucositis. Based on evidence-based practice, develop a standardized nursing protocol for cancer therapy-related oral mucositis that aligns with China's national context and demonstrates strong clinical feasibility, and establish a clinical management pathway for cancer therapy-related oral mucositis. Validate the implementability of the standardized nursing protocol, and evaluate its clinical effectiveness and cost-effectiveness.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100144
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with a confirmed cancer diagnosis who are aware of their condition.
  • Patients currently undergoing non-surgical treatments such as chemotherapy, radiotherapy, immunotherapy, or targeted therapy.
  • Patients who voluntarily agree to participate in this study and provide informed consent.

Exclusion Criteria:

  • Patients with autoimmune diseases;
  • Patients with primary or metastatic oral or lip cancer.;
  • Patients who are participating in other intervention studies.;
  • Swallowing problems existed in patients with Kubota drinking test > level 3;
  • Coma or inability to open mouth, difficulty cooperating with the researcher.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
In addition to providing patients with oral hygiene education (brushing teeth twice daily and rinsing with water after meals) and administering symptomatic treatment as prescribed, during their outpatient infusion visits, nurses will deliver evidence-based nursing interventions for cancer therapy-related oral mucositis through face-to-face education and guidance. Following discharge, patients will receive weekly online follow-up visits to enhance adherence to the protocol. Additionally, patients will be monitored for any adverse reactions or intolerance symptoms-such as nausea and vomiting-during the implementation of the evidence-based oral mucositis care regimen.
Behavioral: Conventional nursing measures
Conventional nursing measures were provided, entailing patient education on oral care (brushing twice daily and rinsing with plain water postprandially), as well as symptom management according to established protocols.
Other Names:
  • Control group
Experimental: Intervention group
In addition to providing patients with oral hygiene education (brushing teeth twice daily and rinsing with water after meals) and administering symptomatic treatment as prescribed, during their outpatient infusion visits, nurses will deliver evidence-based nursing interventions for cancer therapy-related oral mucositis through face-to-face education and guidance. Following discharge, patients will receive weekly online follow-up visits to enhance adherence to the protocol. Additionally, patients will be monitored for any adverse reactions or intolerance symptoms-such as nausea and vomiting-during the implementation of the evidence-based oral mucositis care regimen.
Behavioral: Intervention group
In addition to providing patients with oral hygiene education (brushing teeth twice daily and rinsing with water after meals) and administering symptomatic treatment as prescribed, during their outpatient infusion visits, nurses will deliver evidence-based nursing interventions for cancer therapy-related oral mucositis through face-to-face education and guidance. Following discharge, patients will receive weekly online follow-up visits to enhance adherence to the protocol. Additionally, patients will be monitored for any adverse reactions or intolerance symptoms-such as nausea and vomiting-during the implementation of the evidence-based oral mucositis care regimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of oral mucositis
Time Frame: One treatment cycle (21days)
WHO Oral Mucositis Assessment Scale
One treatment cycle (21days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral Condition Assessment
Time Frame: One treatment cycle (21days)
Oral Assessment Guide
One treatment cycle (21days)
Salivary pH
Time Frame: One treatment cycle (21days)
Salivary pH was measured using pH test paper. Prior to testing, participants were required to fast (including no food or water) for one hour and to avoid activities that might alter salivary composition, such as using mouthwash, brushing teeth, smoking, or chewing gum. After one hour, a saliva sample was collected. Using a dropper, a sample was placed onto the pH test paper until it was fully saturated. After waiting for 10 seconds, the color change was compared against a standard color chart. Normal salivary pH typically falls within the range of 6.6 to 7.1, with a lower pH value indicating higher salivary acidity.
One treatment cycle (21days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

December 12, 2025

First Submitted That Met QC Criteria

December 12, 2025

First Posted (Actual)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 12, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No. PUMCSON-2023-26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Published on ResMan (http://www.medresman.org.cn/)

IPD Sharing Time Frame

Publication date: January 30, 2028

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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