Evaluating the evaluation of calendula oil nanoemulsion containing hydrocortisone in dermatitis following radiotherapy in breast cancer: a randomized clinical trial

Evaluating the evaluation of calendula oil nanoemulsion containing hydrocortisone in management of dermatitis following radiotherapy in breast cancer: a randomized double blind clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240213061001N1

Enrollment

Registered

2024-07-03

Start date

2024-07-22

Completion date

Unknown

Last updated

2024-07-22

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

Conditions

dermatitis following radiotherapy in breast cancer. Disorder of the skin and subcutaneous tissue related to radiation, unspecified

Interventions

Intervention 1: First intervention group: gel containing calendula oil nanoemulsion containing 1% hydrocortisone: Twice a day for up to 6 weeks topically - clean the area with a wet towel before use.

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Female patients at least 18 years old Patients with breast cancer who have undergone surgery (or adjuvant treatment) or received neoadjuvant chemotherapy and underwent surgery. Candidates for breast radiotherapy

Exclusion criteria

Exclusion criteria: Complete mastectomy Background or active skin disease Breast wound that has not been repaired Allergy to hydrocortisone Allergy to marigold essential oil

Design outcomes

Primary

Measure	Time frame
Complications based on CTCAE v5.0 early complication scoring system. Timepoint: Before starting radiation therapy and on days 7, 14 and 21 of radiation therapy. Method of measurement: Visual Analogue Scale.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamid-Reza Sadoughi

Bojnourd University of Medical Sciences

ha.sa.2005@gmail.com+98 58 3229 7095

Outcome results

None listed

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