Dexpanthenol Mouthwash to Treat Oral Mucositis

NCT ID: NCT01318889

Last Updated: 2011-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Oral mucositis can be a significant problem for cancer patients. It is typically associated with pain and increased risk of infection and can lead to impaired nutritional status and inadequate hydration.it can be seen in the patient population receiving high-dose head and neck radiation therapy (85%-100%). Topical dexpanthenol acts like a moisturizer, improving stratum corneum hydration, reducing transepidermal water loss and maintaining skin softness and elasticity. The stimulation of epithelization, granulation and mitigation of itching were the most prominent effects of formulations containing dexpanthenol. The investigators suppose that dexpanthenol mouth wash may improve oral mucositis.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients will be given a bottle of 5% Dexpanthenol mouthwash and they are asked to rinse 10 ml of it three times a day. At the onset of mucositis and then for 4 subsequent weeks they will be examined to evaluate the condition of their oral mucosa.By the advent of mucositis stage 4 ,at any time during the 4 weeks of study,the patient would be out.if any patient shows allergic reaction to dexpanthenol,he/she would be out of study too.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oral Mucositis (Ulcerative) Due to Radiation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

normal saline

mouth wash of normal saline ,three times a day, 10 cc each time

Group Type EXPERIMENTAL

Dexpanthenol

Intervention Type DRUG

5% dexpanthenol Mouth wash , three times a day, 10 cc each time

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexpanthenol

5% dexpanthenol Mouth wash , three times a day, 10 cc each time

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Physiologic serum

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. without any systemic disease
2. estimated survival of at least 6 months
3. without any mental disorders
4. grade 1 to 3 WHO mucositis

Exclusion Criteria

1. development of grade 4 WHO mucositis
2. Brachytherapy
3. allergy to the drug
4. dissatisfaction of the patient
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dental Faculty of shaheed Beheshti medical University

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fahimeh Anbari, resident

Role: PRINCIPAL_INVESTIGATOR

dental faculty of shaheed Beheshti medical university

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

ShaheedBeheshti medical university

Tehran, , Iran

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Iran

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Fahimeh Anbari, resident

Role: CONTACT

+98 9197263620

Jamileh beigom Taheri, professor

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Fahimeh Anbari, postgraduate student

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BMU1360

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mouth Care Regimes During Radiotherapy
NCT00138827 COMPLETED PHASE4