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Topical Timolol Effectiveness for prophylaxy of radiation induced dermatitis in breast cancer patients

Topical Timolol Effectiveness for prophylaxy of radiation induced dermatitis in breast cancer patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190810044500N11
Enrollment
64
Registered
2021-03-17
Start date
2020-08-22
Completion date
Unknown
Last updated
2021-04-26

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

Interventions

Intervention 1: Intervention group:Topical 0.5% timolol gel is made by the operator in the laboratory. Patients with breast cancer referred to the center Radiation therapy is included in the study. Pa

Sponsors

Yazd University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients older than 18 years with positive histology confirm invasive and localized breast cancer, who are candidates for adjuvant radiotherapy after surgery (breast conserving or mastectomy). Adequate literacy to fill out a consent form, understand the study, use the drug, report pain and possible side effects

Exclusion criteria

Exclusion criteria: Inflammatory or metastatic carcinoma Extensive skin diseases Connective tissue diseases known sensitivity to beta-antagonist drugs

Design outcomes

Secondary

MeasureTime frame
Quality of Life. Timepoint: Before and after intervention. Method of measurement: According to the questionnaire EORTC QLQ-C30 (version 3).;When the complication occurs. Timepoint: From the beginning of the intervention to two weeks after the end of radiotherapy. Method of measurement: Based on the doctor's observation and the person's statements.

Primary

MeasureTime frame
Acute Radiation Dermatitis. Timepoint: Weekly during radiotherapy and two weeks after the end of radiotherapy. Method of measurement: Based on the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (RTOG / EORTC).;Moist desquamation. Timepoint: Weekly during radiotherapy and two weeks after the end of radiotherapy. Method of measurement: Based on the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0).;The worst pain experienced. Timepoint: once every two weeks. Method of measurement: Based on Dermatology Life Quality Index (DLQI).;Patient' skin phototype. Timepoint: Before starting radiotherapy. Method of measurement: Based on the Fitzpatrick skin phototype scale.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactzahra hakimi

Yazd University of Medical Sciences

zahra.hakimi1997@gmail.com+98 35 3820 3419

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 13, 2026