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Completed

NCT Number: NCT07305766

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

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.

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Key information

Conditions

Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stomatitis Stomatognathic Diseases Ulcer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100144, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention Group

Behavioral

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.

Conventional nursing measures

Behavioral

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

Primary outcomes

  1. Incidence of oral mucositis

    Time frame: One treatment cycle (21days)

    WHO Oral Mucositis Assessment Scale

Secondary outcomes

  1. Oral Condition Assessment

    Time frame: One treatment cycle (21days)

    Oral Assessment Guide

  2. 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.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 26, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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