Evaluation of topical sylimarin formulation efficacy in prevention of radiotherapy induced skin reactions in breast cancer patients

Evaluation of topical sylimarin formulation efficacy in prevention of radiodermatitis in breast cancer patients

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016110730760N1

Enrollment

Registered

2017-11-01

Start date

2017-08-23

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. Radiodermatitis, unspecified

Interventions

Intervention 1: Silymarin ointment produced by Goldaru Company, twice daily on breasts, for 5.5 weeks after radiotherapy. Intervention 2: Placebo ointment produced by Goldaru Company, twice daily on b

Treatment - Drugs

Placebo

Silymarin ointment produced by Goldaru Company, twice daily on breasts, for 5.5 weeks after radiotherapy

Placebo ointment produced by Goldaru Company, twice daily on breasts, for 5.5 weeks after radiotherapy

Eligibility

Sex/Gender

Female

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Age above 18 years; Breast cancer patients after mastectomy undergoing radiotherapy; X-ray total dose of 50.4 GY Exclusion criteria: Diabetes; Smoking; Anti inflammatory drugs; Immunosuppressor drugs; Immunodeficiency diseases; Connective tissue diseases

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Radiodermatitis occurrence. Timepoint: 1 week after intervention,2week after intervention,3week after intervention,4week after intervention,5week afterintervention. Method of measurement: NCI CTCAE version 4.03 and Acute Radiation Morbidity Scoring Criteria (RTOG).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHedyieh Karbasforooshan

Mashhad University of Medical Sciences

karbasfh911@mums.ac.ir+98 51 3180 1588

Outcome results

None listed

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