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Manufacture of propranolol 3% gel and comparing it with placebo in the prevention of radiotherapy induced dermatitis in breast cancer patients

Manufacture of propranolol 3% gel and comparing it with placebo in the prevention of radiotherapy induced dermatitis in breast cancer patients; A double-blind clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190425043368N4
Enrollment
56
Registered
2026-05-23
Start date
2026-05-24
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Radiotherapy induced dermatitis. Acute radiodermatitis

Interventions

Intervention 1: Intervention group: Recipient of 3% Propranolol Gel. Propranolol hydrochloride powder was obtained from Daroupakhsh Pharmaceutical Chemical Company and the gels are made weekly in the

Sponsors

Yazd University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Pathological diagnosis of breast cancer Patients who have not had their entire breast removed Radiotherapy recipient with a maximum dose of 60 Gy in 200 cGy fractions

Exclusion criteria

Exclusion criteria: People with known allergies or contraindications to beta-blockers Unwillingness to sign the consent form Inflammatory metastatic carcinoma Concomitant use of other antioxidant drugs Connective tissue diseases or chronic skin disease

Design outcomes

Primary

MeasureTime frame
Acute radiation dermatitis (ARD) grade. Timepoint: Weekly for up to 6 weeks. Method of measurement: Based on Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC) and Common Terminology Criteria for Adverse Events (CTCAE) version 5.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahtabalsadat Mirjalili

Yazd University of Medical Sciences

Mahtab.mirjalili@gmail.com+98 35 3820 3419

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026