Randomized, controlled clinical study of five-color herbal gel in the prevention of acute radiation dermatitis

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2024000371

Enrollment

Unknown

Registered

2024-09-04

Start date

2024-09-02

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

radiodermatitis

Interventions

test team:External application of five-color herbal gel, 1 time a day

control group:Apply 0.1 % mometasone furoate or 0.1 % hydrocortisone butyrate cream externally, 1 time a day

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: ( 1 ) 18-80 years old ; ( 2 ) Breast cancer diagnosed by histopathology ( 2023 Breast Cancer Diagnosis and Treatment Guidelines ), patients with initial radiotherapy ; ( 3 ) Irradiation site : armpit, chest wall ; ( 4 ) The main organ function is normal, which meets the following criteria : 1 Blood routine examination standards should be met ( no blood transfusion and blood products within 14 days, no use of G-CSF and other hematopoietic stimulating factors to correct ) : a.HB = 90g / L ; b.ANC = 1.5 × 109 / L ; pLT = 80 × 109 / L ; 2 Biochemical examination should meet the following criteria : a. TBIL 45ml / min ( Cockcroft-Gault formula ) ; ( 5 ) ECOG score was 0-1, and the expected survival time was more than 3 months. ( 6 ) Treatment plan : After radical mastectomy, breast cancer patients were treated with 6MV-X-ray and electron beam mixed conventional fractionated irradiation, with a dose of 2.0Gy, once a day, 5 times a week, for 5 weeks, with a total dose of 50Gy. After breast-conserving surgery, 6MV-X-ray irradiation was used to routinely segment the irradiation dose.

Exclusion criteria

Exclusion criteria: ( 1 ) High allergic constitution ; ( 2 ) There were connective tissue diseases or unhealed scars in the irradiated area before radiotherapy ; ( 3 ) patients with skin-related diseases such as local dermatitis and breakage ; ( 4 ) The researchers judged other situations that may affect the conduct of clinical research and the determination of research results.

Design outcomes

Primary

Measure	Time frame
The incidence and severity of radiation dermatitis;	—

Secondary

Measure	Time frame
Skin moisture content test;Incidence of radiotherapy cessation;NRS;VAS;Radiation-Induced Skin Response Assessment Scale ( RISRAS );Dermatology Life Quality Index, DLQI;	—

Countries

China

Contacts

Public ContactLou Yanni

china-japan friendship hospital

louyanni@hotmaiml.com+86 186 0132 7716

Outcome results

None listed

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