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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07305766
Enrollment
54
Registered
2025-12-26
Start date
2023-10-01
Completion date
2024-12-31
Last updated
2025-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy

Keywords

Evidence-Based Nursing Protocol, Oral Mucositis

Brief summary

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.

Interventions

BEHAVIORALIntervention 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.

BEHAVIORALConventional 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.

Sponsors

Peking Union Medical College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of oral mucositisOne treatment cycle (21days)WHO Oral Mucositis Assessment Scale

Secondary

MeasureTime frameDescription
Oral Condition AssessmentOne treatment cycle (21days)Oral Assessment Guide
Salivary pHOne 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026