Oral Care Interventions in PEG-Fed Palliative Care Patients

NCT07792473 | Not Yet Recruiting

• 1 other identifier: YKU-PEG-ORALCARE-2026-01
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This pilot randomized controlled trial will compare three oral care interventions in adult palliative care patients who receive enteral nutrition through a percutaneous endoscopic gastrostomy (PEG) tube. The purpose of the study is to determine how these oral care interventions affect the health and integrity of the oral mucosa. Participants will be randomly assigned to one of three groups: oral care with Ankaferd Hemostat, benzydamine hydrochloride, or a combined solution containing methylprednisolone, ceftriaxone, and sodium bicarbonate. Oral care will be provided by trained nurses according to a standardized protocol. Participants' mouths will be assessed at the beginning of the study and on days 7 and 15. These assessments will include examination of the oral mucosa and standardized photographs of the mouth. Relevant clinical and laboratory information available as part of routine patient care will also be recorded. The findings will be used to compare changes in oral mucosal health among the three groups.

Conditions

Oral Mucosal Integrity; Palliative Care; PEG Feeding

Keywords

Percutaneous Endoscopic Gastrostomy; Enteral Nutrition; Palliative Care; Oral Care; Oral Mucosal Integrity; Ankaferd Hemostat; Benzydamine Hydrochloride; Methylprednisolone; Ceftriaxone

Outcome Measures

Primary Outcomes (1)

• Change in Oral Mucositis Assessment Scale (OMAS) Score

  Oral mucosal integrity will be assessed using the Oral Mucositis Assessment Scale (OMAS), which evaluates ulceration/pseudomembrane and erythema at predefined oral sites. Ulceration is scored from 0 to 3 and erythema from 0 to 2, with higher scores indicating greater oral mucosal damage.

  Baseline (Day 0), Day 7, and Day 15

Study Arms (3)

Arm 1 - Ankaferd Hemostat

EXPERIMENTAL

Arm 1 - Ankaferd Hemostat Participants assigned to this arm will receive standardized oral care followed by topical application of Ankaferd Hemostat. For each application, 1 mL of Ankaferd Hemostat will be mixed with 4 mL of sterile water to obtain a total volume of 5 mL. The solution will be applied to the oral mucosal surfaces by trained nurses twice daily, approximately 12 hours apart, for 15 days. The solution will not be swallowed.

Drug: Ankaferd Hemostat

Arm 2 - Benzydamine Hydrochloride

EXPERIMENTAL

Arm 2 - Benzydamine Hydrochloride Participants assigned to this arm will receive standardized oral care followed by topical application of 0.15% benzydamine hydrochloride. The solution will be applied to the oral mucosal surfaces by trained nurses twice daily for 15 days. Because participants are fed through PEG and may have an increased risk of aspiration, the solution will not be used as a gargle and will not be swallowed.

Drug: Benzydamine Hydrochloride 0.15% w/v oromucosal solution

Arm 3 - Combined Oral Care Solution

EXPERIMENTAL

Arm 3 - Combined Oral Care Solution Participants assigned to this arm will receive standardized oral care followed by topical application of a combined solution containing 40 mg methylprednisolone, 1000 mg ceftriaxone, and 0.84 g sodium bicarbonate. The final solution volume will be 25 mL and will be prepared with normal saline according to the standardized clinical preparation procedure. The solution will be applied to the oral mucosal surfaces by trained nurses twice daily, approximately 12 hours apart, for 15 days. The solution will not be swallowed.

Drug: Combined Oral Care Solution

Interventions

Ankaferd Hemostat DRUG

Ankaferd Hemostat will be used as a topical oral care intervention. For each application, 1 mL of Ankaferd Hemostat will be mixed with 4 mL of sterile water to obtain a total volume of 5 mL. The prepared solution will be applied to the oral mucosal surfaces by a trained nurse twice daily, approximately 12 hours apart, for 15 days. The solution will not be swallowed.

Arm 1 - Ankaferd Hemostat

Benzydamine Hydrochloride 0.15% w/v oromucosal solution DRUG

Benzydamine hydrochloride 0.15% will be used as a topical oral care intervention. The solution will be applied to the oral mucosal surfaces by trained nurses twice daily for 15 days. Because participants receive enteral nutrition through PEG and may have an increased risk of aspiration, the solution will not be used as a gargle and will not be swallowed.

Arm 2 - Benzydamine Hydrochloride

Combined Oral Care Solution DRUG

A combined oral care solution containing 40 mg methylprednisolone, 1000 mg ceftriaxone, and 0.84 g sodium bicarbonate will be used as a topical oral care intervention. Ceftriaxone will be diluted with 10 mL normal saline, methylprednisolone with 5 mL normal saline, and sodium bicarbonate will be added to obtain a final volume of 25 mL. The prepared solution will be applied to the oral mucosal surfaces by trained nurses twice daily, approximately 12 hours apart, for 15 days. The solution will not be swallowed.

Arm 3 - Combined Oral Care Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older. Hospitalized in a palliative care unit. Receiving enteral nutrition via percutaneous endoscopic gastrostomy (PEG). PEG feeding expected to continue throughout the 15-day study period. Able to undergo baseline oral assessment. No clinical condition preventing the application of oral care. No known allergy or hypersensitivity to any component of the study interventions.
• Written informed consent provided by the participant or, when the participant lacks decision-making capacity, by a legally authorized representative.

You may not qualify if:

• Active and severe bleeding in the oral cavity. Extensive traumatic or surgical oral lesions that prevent oral care. Requirement for another therapeutic topical oral antibiotic, corticosteroid, or antiseptic solution at study entry.
• Known hypersensitivity to Ankaferd Hemostat, benzydamine hydrochloride, ceftriaxone or other cephalosporins, methylprednisolone, or any other component of the study interventions.
• Clinical condition for which the study-related oral care intervention is considered inappropriate by the treating physician.
• Terminal condition in which participation or study procedures are considered likely to adversely affect patient comfort.

Sponsors & Collaborators

• University of Yalova: lead
• Yalova training and research hospital: collaborator

Related Publications (1)

• Sonis ST, Eilers JP, Epstein JB, et al. Validation of a new scoring system for the assessment of clinical trial research of oral mucositis induced by radiation or chemotherapy. Cancer. 1999;85(10):2103-2113. PMID: 10326686 Epstein JB, Silverman S Jr, Paggiarino DA, et al. Benzydamine HCl for prophylaxis of radiation-induced oral mucositis: results from a multicenter, randomized, double-blind, placebo-controlled clinical trial. Cancer. 2001;92(4):875-885. PMID: 11550161 Puhar I, Paleško Tubikanec T, Glavina S, et al. Effect of Benzydamine Hydrochloride on Dental Plaque Accumulation During Short-Term Restricted Oral Hygiene: A Randomized, Placebo-Controlled Trial. Pharmaceuticals. 2026;19:1013. Berk D, Durna Z, Akın S. Kemoterapi uygulanan kanser hastalarında ağız bakımı uygulamaları ve ağız bakım alışkanlıklarının değerlendirilmesi. Sağlık ve Toplum. 2020;30(2):54-63. Kasnak G, Fıratlı HE. Antimikrobik gargara kullanımının ağız mikrobiyotasına etkisi. In: Altındiş M, ed. Ağız Mikrobiyotası. İstanbul: Nobel Yayın Dağıtım; 2022:263-287. Dağyar K. Oral Mukoza Hastalıklarının Tedavisinde Kortikosteroid Kullanımı. Bitirme Tezi. İstanbul Üniversitesi Diş Hekimliği Fakültesi; 2021.

  BACKGROUND

MeSH Terms

Interventions

Benzydamine

Intervention Hierarchy (Ancestors)

Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Yasemin Karacan, PhD

CONTACT

05327141814; jblacksoul@yahoo.com

Irem Ozturk Bardak, RN

CONTACT

irem.ozturk@yalova.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Yalova Universitesi Division of Nursing, Health Science Faculty

Model Details: Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel oral care intervention groups and will remain in their assigned group throughout the 15-day study period.

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): September 7, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months after publication of the study results and available for 5 years.
• Access Criteria: De-identified individual participant data and supporting information will be available to qualified researchers who submit a methodologically sound research proposal. Requests should be submitted to the corresponding author and will be reviewed by the research team. Access will be granted for approved research purposes and in accordance with applicable ethical and institutional requirements.