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Investigating the effect of Rosa damascene extract on burns caused by radiation therapy

The effect of the traditional medicinal product of Rosa damascene in prevention of radiodermatitis in patients with breast cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241006063271N1
Enrollment
60
Registered
2024-10-09
Start date
2024-10-06
Completion date
Unknown
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatitis caused by radiotherapy. Radiodermatitis

Interventions

Intervention 1: Intervention group: The product containing rose extract based on olive oil (prepared by a pharmacist under the supervision of the Faculty of Pharmacy) will be prepared and will be give

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Women with breast cancer confirmed by histology which are candidates for radiation therapy

Exclusion criteria

Exclusion criteria: Inflammatory or metastatic breast cancer Severe infection requiring antibiotic treatment History of previous radiation therapy for breast cancer Diabetes Inflammatory skin disorders Connective tissue disorders Simultaneous use of non-steroidal anti-inflammatory drugs Simultaneous use of corticosteroids and other drugs that suppress the immune system or antioxidants. The presence of any wounds, scars, burns and any other previous skin damage at the radiation therapy site Patients with allergy or hypersensitivity to intervention ingredients

Design outcomes

Primary

MeasureTime frame
Dermatitis based on CTCAE grading to evaluate the side effects of radiation therapy on the skin. Timepoint: Before starting the intervention, the end of each week for 5 weeks. Method of measurement: CTCAE form version 5 to evaluate skin dermatitis caused by radiation therapy.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMozhdeh Sanei

Shiraz University of Medical Sciences

sanei_m@sums.ac.ir+98 71 3626 9094

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026