Chemotherapy-Induced Oral Mucositis in Breast Cancer
Conditions
Interventions
Experimental Group:Licorice Xiexin Decoction oral
Control Group:Vitamin B2 oral
Sponsors
Shanghai University of Traditional Chinese Medicine Affiliated Longhua Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Primary breast tumor confirmed as malignant by core needle biopsy or surgical biopsy; 2) Meeting indications for breast cancer chemotherapy after evaluation; 3) Oral mucositis of Grade I or above [*Diagnostic grading criteria for oral ulcers refer to WHO Chemotherapy Drug Toxicity Grading Standards (NCI-CTC 3.0): Grade 0: Normal oral mucosa; Grade I: Oral mucosal erythema/pain without impaired eating; Grade II: Single ulcer >1.0cm or multiple ulcers with increased pain, tolerating semi-liquid diet; Grade III: Two ulcers >1.0cm, tolerating liquid diet only; Grade IV: Confluent ulcers with severe pain and inability to eat]; 4) Karnofsky score =60; 5) Female patients aged 18-75 (inclusive); 6) No severe organic/functional disorders or drug/food allergies; 7) Voluntary participation with signed informed consent.
Exclusion criteria
Exclusion criteria: 1) Not meeting inclusion criteria; 2) Expected survival <6 months; 3) Severe cardiovascular, hepatic, renal, hematopoietic system diseases or mental disorders; 4) Pregnant/lactating women or those planning pregnancy; 5) Allergic constitution or multiple drug allergies; 6) Participating in other drug trials; 7) Receiving radiotherapy; 8) Oral autoimmune diseases (e.g., Behçet's disease, pemphigus), active oral infections (fungal/viral/bacterial), orthodontic treatment, or dental implants confirmed by dentists.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oral ulcer healing time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Oral ulcer healing efficacy rate;Pain score;Recurrence rate;Traditional Chinese Medicine Syndrome Scoring Scale; | — |
Countries
China
Contacts
Public ContactLiu Sheng
Shanghai University of Traditional Chinese Medicine Affiliated Longhua Hospital
Outcome results
None listed