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The study of radioprotective effects of topical atorvastatin gel on skin toxicity in breast cancer radiotehrapy: a double-blind randomized, placebo- controlled clinical trial

The study of radioprotective effects of topical atorvastatin gel on skin toxicity in breast cancer radiotehrapy: a double-blind randomized, placebo- controlled clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016062219423N2
Enrollment
60
Registered
2016-07-20
Start date
2016-09-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Radiodermatitis. Malignant neoplasm of breast, Acute radiodermatitis

Interventions

Intervention 1: Patients undergoing radiotherapy will receive topical atorvastatin containing BD. Gel toically will be administrated on skin of breast. Intervention 2: Patients undergoing radiotherapy
Treatment - Drugs
Placebo
Patients undergoing radiotherapy will receive topical atorvastatin containing BD. Gel toically will be administrated on skin of breast.
Patients undergoing radiotherapy will receive placebo topica. Gel toically will be administrated on skin of breast. l

Sponsors

Vice Chancellor for Research and Technology, Mazandaranl University of Medical Scenices
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Adults over 18 years and less 70 years; breast cancer; about 50Gy total dose of radiation. Exclusion criteria: Smoking; sing the anti-inflammatory drug such as dexametasone and NSAID; active skin infection and dermatitis; using any topical products on breast; the disease weakens related to the immune system and a lack of diabetes that affected on wound healing; diseases related to kidney and liver.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Severity of radiation-induced skin toxicity (such as Erythema, dry desquamation, itching, and ulcer). Timepoint: Just before drug treatment and then weekly for end of radiotehrapy. Method of measurement: According to RTOG scoring system with a questionnair.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Seyed Jalal Hosseinimehr

Department of Radiopharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences

sjhosseinim@yahoo.com+98 11 3354 3691

Outcome results

None listed

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