The effect of Portulaca oleracea hydrogel on the prevention of radiotherapy-induced dermatitis

Phase 2

Recruiting

• Conditions: Radiotherapy-induced mucositis is breast-conserving cancer patients.; Acute radiodermatitis, Localized skin eruption due to drugs and medicament; L58.0, L27

• Registration Number: IRCT20180103038199N8
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

Female patients diagnosed with breast tissue cancer
Age over 18 years
No concomitant chemotherapy
No previous radiotherapy to the chest area
Minimum radiation of 50 Gy during treatment
BMI 20-30
Breast conserving surgery

Exclusion Criteria

Existence of underlying diseases
hypersensitivity to Portulaca oleracea
Patients with metastatic carcinoma to the breast
Inability of the patient to implement the treatment protocol

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of dermatitis. Timepoint: At the beginning of the study and every week for 6 weeks. Method of measurement: Physician evaluation checklist of incidence and severity of disease for the radiotherapy oncology group (RTOG).;Severity of dermatitis. Timepoint: At the beginning of the study and every week for 6 weeks. Method of measurement: Physician evaluation checklist of incidence and severity of disease for the radiotherapy oncology group (RTOG).

Secondary Outcome Measures

Name	Time	Method
Quality of life. Timepoint: at the beginning and the end of the study. Method of measurement: Ware & Sherbourne's quality of life questionnaire.