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Effect of a combined topical formulation of Plantago major leafs and Rosa damascena oil on prevention of acute radiation dermatitis in breast cancer patients

Investigating the effect of a combined topical formulation of Plantago major leafs and Rosa damascena oil on prevention of acute radiation dermatitis in breast cancer patients- A randomized double-blind placebo-controlled clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20150830023823N5
Enrollment
100
Registered
2026-01-09
Start date
2026-02-20
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Acute radiodermatitis. Acute radiodermatitis

Interventions

Intervention 1: Intervention group:The drug of the intervention group is a combined topical formulation of Plantago major leafs extract and Rosa damascena oil that is made by the Knowledge-Based Phar

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with a definitive diagnosis of breast cancer who have undergone quadrantectomy and are scheduled to receive a course of external radiotherapy to the chest wall 18 years old and more

Exclusion criteria

Exclusion criteria: Previous history of radiotherapy to the chest wall A skin tumor, rash, ulcer, or unhealed scar in the area under radiation History of connective tissue disorders History of diabetes mellitus Concomitant use of chemotherapy

Design outcomes

Primary

MeasureTime frame
Incidence and the severity of dermatitis. Timepoint: weekly for 7 week. Method of measurement: Physician observation with Common Terminology criteria for Adverse Events (CTCAE) version 6.

Secondary

MeasureTime frame
Burning sensation grade. Timepoint: Weekly. Method of measurement: Questioning the patient with the Patient Symptom Scale.;Pain severity. Timepoint: Weekly. Method of measurement: Questioning the patient with the Patient Symptom Scale.;Pruritus severity. Timepoint: Weekly. Method of measurement: Questioning the patient with the Patient Symptom Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Tavakoli

Shiraz University of Medical Sciences

tavakkolia@sums.ac.ir+98 71 3234 5145

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026