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Effect of Plantago major leaf gel on prevention of acute radiation dermatitis in breast cancer patients

Effect of Plantago major leaf gel compared to placebo on prevention of acute radiation dermatitis in breast cancer patients: A double blind, randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20150830023823N4
Enrollment
80
Registered
2021-07-31
Start date
2021-08-21
Completion date
Unknown
Last updated
2021-08-30

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

Conditions

Acute radio dermatitis. Acute radio dermatitis

Interventions

Intervention 1: Intervention group: The drug of the intervention group is Plantago major leaf gel. This topical skin gel is made by a pharmacist under the supervision of Shiraz School of Pharmacy.To

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with definitive diagnosis of breast cancer who have undergone quadrantectomy treatment. indication of external radiotherapy 18 years old and more

Exclusion criteria

Exclusion criteria: previous breast radiotherapy skin tumor rash, ulcer, scar connective tissue disorder diabetes melitus concomitant use of chemotherapy

Design outcomes

Primary

MeasureTime frame
Dermatitis grade. Timepoint: weekly for 7 weeks. Method of measurement: observation by physician with Common Terminology Criteria for Adverse Events(CTCAE) version 4.

Secondary

MeasureTime frame
Burning sensation grade. Timepoint: weekly. Method of measurement: Ask the patient with patient symptom scale.;Pain. Timepoint: weekly. Method of measurement: Ask the patient with patient symptom scale.;Pruritus. Timepoint: weekly. Method of measurement: Ask the patient with 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 4, 2026