Comparative effects of Vitamin E, Hyaloronic acid and Triamcinolone combination versus Triamcinolone alone on oral mucositis induced by radiotherapy

Phase 3

Conditions: Oral mucositis induced by radiotherapy.
Oral mucositis (ulcerative) due to radiation
K12.33

Registration Number: IRCT20190428043407N1

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 58

Inclusion Criteria

Patient entry requirements include: Patients with (at least 18 years of age) (no maximum age limit, Patients with definite cervical cancer diagnosis according to histopathologic examination, Observe oral hygiene in a way that does not prevent the degree of mucositis severity, The patient has the ability to use mouthwash, Grade 3 and 4 oral mucositis according to WHO grade, No history of susceptibility to the drugs studied (so that patients are asked about drug sensitivities prior to entering the study and if they have not a history of hypersensitivity, they are included in the study, Signing consent form informed

Exclusion Criteria

Patient withdrawal criteria from the study include: Pregnant women who recently used (3 weeks) vitamin E and other supplemental antioxidants, Patients with other active oral lesions (such as major asthma), History of alcohol use, Drugs - Performing previous radiotherapy treatments and current chemotherapy treatments and bone marrow transplants with clinical, neurological, endocrine and other systemic diseases. Karnofsky performance status scale less than 60 (Patients in need of admission)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PAIN. Timepoint: weeks1,2,3,4. Method of measurement: Numerical pain scale.;The rate of improvement in the severity of oral lesions. Timepoint: possible change of oral mucositis grade from 3 and 4 to steady levels. Method of measurement: WHO Grading.;Type of prescription. Timepoint: weeks 1,2,3,4. Method of measurement: Based on the study method.;Period of time. Timepoint: Date of referral of patients in weeks 1, 2, 3 and4. Method of measurement: Week 1 and 2, 3, and 4 Treatments.;Gender. Timepoint: Date of referral of patients. Method of measurement: observation.;Age. Timepoint: Date of referral of patients. Method of measurement: Ask the patient.

Secondary Outcome Measures

Name	Time	Method
ack of the mouth wash tolerance is noted by patients and the study will be stopped if there are significant numbers of these people. Timepoint: weeks 1,2,3,4. Method of measurement: ask the patient.