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Hydrogel for prevention of breast cancer skin inflammation during radiotherapy

Investigating the Effects of Hydrogel in Preventing Radiation-Induced Skin Reactions in Breast Cancer Patients with Breast-Conserving Surgery(BCS): Double-Blind Randomized Controlled Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241018063405N1
Enrollment
90
Registered
2024-10-25
Start date
2024-10-29
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Radio-dermatitis in breast cancer. Disorder of the skin and subcutaneous tissue related to radiation, unspecified

Interventions

Intervention 1: Intervention group: Hydrogel containing Calendula oil extract - Jojoba oil extract - Carbomer - Ploxamer 407 - Vitamin E - Glycerin stearate (GMS) - Chlorhexidine - Deionized water - S

Sponsors

FIDAR DAROO Company
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients who volunteer to participate in this study Breast cancer patients who undergo radiotherapy for treatment Patients with age above 18 years and below 75 years Patients who have not received radiotherapy before

Exclusion criteria

Exclusion criteria: Breast cancer patients with mastectomy Pregnant patients Patients with skin diseases

Design outcomes

Primary

MeasureTime frame
Radiation-induced skin reactions in breast cancer patients with breast-conserving surgery. Timepoint: Once a week during radiotherapy treatment - two weeks and four months after completion of treatment. Method of measurement: Using the Common Terminology Criteria for Adverse Events (CTCAE) scale and comparing with the color of the opposite breast.

Secondary

MeasureTime frame
Determining the relationship between the effect of hydrogel and the grade of radiation-induced dermatitis in breast cancer patients with breast-conserving surgery. Timepoint: Once a week during the treatment period, two weeks and 4 months after the end of the treatment. Method of measurement: CTCAE scale.;Once a week during the treatment period, two weeks and 4 months after the end of the treatment. Timepoint: Once a week during the treatment period, two weeks and 4 months after the end of the treatment. Method of measurement: CTCAE scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDanial Fazilatpanah

Babol University of Medical Sciences

m.kharaqani@mubabol.ac.ir+98 11 3527 1791

Outcome results

None listed

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