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The effects of Plantago Major on prevention of radiation induced acute mucositis

Phase 3
Conditions
Radiation-induced mucositis in head and neck cancer.
Oral mucositis (ulcerative)
K12.3
Registration Number
IRCT20190312043027N1
Lead Sponsor
Arak University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
46
Inclusion Criteria

Candidate for radiotherapy for head & neck cancer
Patients with 17-65 years old
Life expectancy over 1 year
Good performance status in Eastern Cooperative Oncology Group (ECOG) questionnaire
At least 4 areas in radiotherapy (RT) ?elds

Exclusion Criteria

Using alcohol
Use of drugs a?ecting salivary gland secretions,such as antidepressants, Opiates, anti-hypertensives, anti-histamines.
Use of mouthwash solutions
Smoking
History of mouth and oropharynx radiation therapy and chemotherapy in the last six months.
History of connective tissue diseases affecting salivary glands such as Sjugren syndrome , Rheumatoid arthritis and Lupus and immunodeficiency diseases
Grade 3-4 mucositis
Candidiasis, oral herpes
Hospitalization or need to Total Parental Nutrition ( TPN)
Dissatisfaction to continue participating in the study
Treatment failed
Diabetes

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Mucositis. Timepoint: Baseline of radiation therapy; every week after initiation of radiation therapy for 5 weeks and two weeks after intervention terminated. Method of measurement: Examination of oral cavity.;Pain. Timepoint: At the baseline and every week from first to seventh. Method of measurement: Visual analogue scale of pain.;Quality of life. Timepoint: At the baseline and every week from first to seventh. Method of measurement: EORTC questionnaire.
Secondary Outcome Measures
NameTimeMethod
Side e?ects. Timepoint: Every week from first to seventh. Method of measurement: Questionnaire.
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