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

Phase 4

• Conditions: Oral mucositis in cancer patients; Vit B2- Dicyclonine Pelicles Preparation; Radiation- induced oral mucositis; Chemotheray- Oral mucositis; Cancer patients; Chrohexidine- Dexamethaosne&#45

• Registration Number: TCTR20150528001
• Lead Sponsor: DON THANI CANCER HOSPITA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-28
• Study Completion: 2015-09-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 60

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

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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