Effectiveness of Black cumin gel in radio-dermatitis in breast cancer

Phase 3

Recruiting

• Conditions: Radiodermatitis; radiodermatitis.

• Registration Number: IRCT20090813002342N7
• Lead Sponsor: Sari University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 September 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Confirmed histological diagnosis of ductal or lobular breast Carcinoma
Adjuvant radiotherapy after surgery

Exclusion Criteria

Patients with previous radiotherapy to the chest or breast
Patients with concomitant adjuvant or neoadjuvant chemotherapy
Generalized skin or connective tissue disorders
Unhealed surgical wounds
A known allergy to Black cumin or any excipient of gel formulation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The time of incidence of radio-dermatitis. Timepoint: At the beginning of the study (before the intervention) and weekly until the end of the radiotherapy period. Method of measurement: Radiation therapy oncology group (RTOG) ? National Cancer institute: Common Terminology Criteria for Adverse Events v5.0 (CTCAE) Scales.

Secondary Outcome Measures

Name	Time	Method
The quality of life of patients. Timepoint: Biweekly after initiation of radiotherapy period. Method of measurement: Dermatology Life Quality Index (DLQI) questionnaire.