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The effect of Portulaca oleracea hydrogel on the prevention of radiotherapy-induced dermatitis

Evaluation of the effectivness of hydrogel containing Purslane extract in prevention and reduction of severity of radiotherapy-induced acute dermatitis in breast cancer patients

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180103038199N8
Enrollment
80
Registered
2021-07-27
Start date
2021-07-23
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

Radiotherapy-induced mucositis is breast-conserving cancer patients. Acute radiodermatitis, Localized skin eruption due to drugs and medicament

Interventions

Intervention 1: Control group: Patients undergo radiotherapy, will receive placebo hydrogel containing glycerin and green dye made by Mashhad University of Medical Sciences. Patients will use this hyd

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Female patients diagnosed with breast tissue cancer Age over 18 years No concomitant chemotherapy No previous radiotherapy to the chest area Minimum radiation of 50 Gy during treatment BMI 20-30 Breast conserving surgery

Exclusion criteria

Exclusion criteria: Existence of underlying diseases hypersensitivity to Portulaca oleracea Patients with metastatic carcinoma to the breast Inability of the patient to implement the treatment protocol

Design outcomes

Primary

MeasureTime frame
Incidence of dermatitis. Timepoint: At the beginning of the study and every week for 6 weeks. Method of measurement: Physician evaluation checklist of incidence and severity of disease for the radiotherapy oncology group (RTOG).;Severity of dermatitis. Timepoint: At the beginning of the study and every week for 6 weeks. Method of measurement: Physician evaluation checklist of incidence and severity of disease for the radiotherapy oncology group (RTOG).

Secondary

MeasureTime frame
Quality of life. Timepoint: at the beginning and the end of the study. Method of measurement: Ware & Sherbourne's quality of life questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactVahid Reza Askari

Mashhad University of Medical Sciences

askariv@mums.ac.ir+98 51 3800 2264

Outcome results

None listed

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