Breast cancer
Conditions
Interventions
Intervention group (phase II):Apply ursodeoxycholic acid to the radiotherapy area
Intervention group (phase I):Apply ursodeoxycholic acid to the radiotherapy area
Sponsors
Mianyang Central Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: A. Women aged 18 years or above who are histologically confirmed as breast cancer; B. 2-4 weeks after completing adjuvant chemotherapy; C. ECOG score 0-1; D. Normal blood routine (neutrophils>1.8 × 109/L, platelets>100 × 109/L, hemoglobin>100g/L), good liver and kidney function (glomerular filtration rate>50 mL/min, transaminase and bilirubin below 2.5 times the normal upper limit); E. The chest has not undergone radiation therapy in the past.
Exclusion criteria
Exclusion criteria: A. Patients with unhealed wounds in the radiation zone; B. Receiving other anti-tumor treatments besides endocrine therapy and anti-her-2 therapy; C. Pregnancy or lactation period; D. Patients who are known to be allergic to ursodeoxycholic acid; E. Patients with acute cholecystitis, cholangitis, biliary obstruction, and biliary colic.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of RID >= grade 2;Therapeutic toxicity ( phase I); | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of RID-related symptoms;Safety of ursodeoxycholic acid for the prevention of RID; | — |
Countries
China
Contacts
Public ContactXiaobo Du
Mianyang Central Hospital
Outcome results
None listed