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A CLINICAL BENEFITS OF PELICLES OTC TOPICAL PREPARATION CONTAINING 1.5 mg CHLORHEXIDINE, 1 mg VITAMIN-B2, 0.05 mg DEXAMETHASONE AND 0.75 mg DYCYCLONINE (CNX01) ON TOP OF STANDARD TREATMENT FOR MANAGEMENT OF ORAL MUCOSITIS AMONG CANCER PATIENTS: A 2-WEEK NON-RANDOMIZED CROSS-OVER DESIGN COMPARED WITH STANDARD TREATMENT ALONE

A CLINICAL BENEFITS OF PELICLES OTC TOPICAL PREPARATION CONTAINING 1.5 mg CHLORHEXIDINE, 1 mg VITAMIN-B2, 0.05 mg DEXAMETHASONE AND 0.75 mg DYCYCLONINE (CNX01) ON TOP OF STANDARD TREATMENT FOR MANAGEMENT OF ORAL MUCOSITIS AMONG CANCER PATIENTS: A 2

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
TCTR
Registry ID
TCTR20150528001
Enrollment
60
Registered
2015-05-28
Start date
2015-07-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Oral mucositis in cancer patients Radiation&#45

Interventions

Cancer Oral Mucositis
Supportive Care
Cancer

Sponsors

UDON THANI CANCER HOSPITAL
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Current and stable cancer patients under medical and/or radiological treatment program whom able to self-support in terms of standard oral hygiene care and self-provisioning of food-intake under the continuous 5FU under planned radiotherapy at least for 5-6 weeks. 2.Current and stable head and neck cancer patients under medical and/or radiological treatment program whom able to self-support in terms of standard oral hygiene care and self-provisioning of food-intake either pre or post-surgical procedure. 3.Current and stable for non-operative patients diagnosed with CA tongue, CA nasopharynx under medical and/or radiological treatment program whom able to self-support in terms of standard oral hygiene care and self-provisioning of food-intake. 4.Current and stable cancer patients under medical and/or radiological treatment program whom painful oral mucositis is a limiting factor which discouraging the follow-up treatment plan determined by specialist in charge. 5.Hospitalized cancer patients under medical and/or radiological treatment program whom deemed necessary to be included in the study by specialist in charge. 6.Current and stable cancer patients under medical and/or radiological program whom had suffering from oral mucositis with ulcer size/area less than 3cm2 and number of ulcer less than 5 ulcers

Exclusion criteria

Exclusion criteria: 1.Cancer patients whom shall not provide patient-inform consent and is a non-compliance in terms of weekly assessment follow-up visit. 2.Cancer patients whom experience severe gastrointestinal distressed symptoms due to progression of severe mucositis other than oral mucositis and therefore routine management of painful symptoms of oral cavity is not feasible. 3.Advance staging cancer patients whom deemed necessary for exclusion by specialist in charge. 4.Cancer patients with HIV positive. 5.Advance staging cancer patients whom deemed for surgical follow-up. 6.Others cancer patients deem clinically inappropriate by investigators. 7.Non-compliance patients whom topical administration of the pelicles shall be less than 2 weeks. 8.Cancer patients whom shall be developing hypersensitivity and allergic reaction due to the topical application of the pelicles.

Design outcomes

Primary

MeasureTime frame
The World Health Organization (WHO) oral toxicity scale. At the ends of each of 2 weeks of treatment Objective and subjective symptoms and functional score assessment ,The Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring At the end of each 2 weeks of treatment Clinician’s judgement on anatomical and functional changes of oral mucositis

Secondary

MeasureTime frame
The Oral Mucositis and Daily Questionnaire (OMDQ) scoring At the ends of each of 2 weeks of treatment A subjective patient-reported outcomes scores

Contacts

Public ContactAnan Udombhornprabha

Eastern Asia University

auyuyg@gmail.com66-89-129-6285

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026