radiodermatitis. Radiodermatitis
Conditions
Interventions
Intervention 1: Intervention group: 5% gel of black seed extract. Intervention 2: Control group: Placebo gel.
Sponsors
Sari University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Confirmed histological diagnosis of ductal or lobular breast Carcinoma Adjuvant radiotherapy after surgery
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| The quality of life of patients. Timepoint: Biweekly after initiation of radiotherapy period. Method of measurement: Dermatology Life Quality Index (DLQI) questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Raza Rafati
Sari University of Medical Sciences
Outcome results
None listed