Breast cancer
Conditions
Interventions
Control Group:In addition to routine treatment, a matched placebo was administered.
Experimental Group:In addition to routine treatment, administer the granules for resolving nodules and tumors.
Sponsors
Hunan Provincial Research Institute of Traditional Chinese Medicine Affiliated Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-75 years, female, voluntarily signed informed consent, able to cooperate with completing the questionnaire assessment and follow-up; 2) Confirmed as breast cancer by histopathology or cytology, and AJCC 8th edition stage I–III, R0 resection, M0; N0–N3 is allowed (if only high-risk population is intended, it should be clearly defined as stage II–III or according to recurrence risk stratification criteria); 3) Have started or plan to start postoperative standard adjuvant therapy; if used for evaluating skin repair outcomes, baseline should have radiation/chemotherapy-related skin damage (e.g., CTCAE skin-related criteria = grade 1 or presence of scabs/ulcers), and it should be set as a predefined subgroup/stratification variable rather than a hard inclusion criterion; 4) ECOG score 0-2, expected survival =36 months; Chinese syndrome consistent with "phlegm-stasis intermingling, liver qi stagnation" (refer to "Guidelines for Clinical Research of New Traditional Chinese Medicine Drugs (2020 Edition)"), and baseline syndrome score =6 points; 5) Completed baseline psychological questionnaire assessment (recommended HADS or PHQ-9/GAD-7; if SAS/SDS is retained, its basis for use in cancer populations should be explained), not as a hard inclusion criterion; 6) No severe abnormalities in major laboratory tests for liver and kidney function, blood routine, coagulation function, etc. (ALT, AST =2.5×ULN, Cr =1.5×ULN, platelets =100×109/L, white blood cells =3.5×109/L).
Exclusion criteria
Exclusion criteria: 1. Participants with allergies related to investigational drugs: Those with known or suspected allergies to any component of the drug "Scatter" or placebo excipients, or those with a history of severe drug allergies (e.g., anaphylactic shock, laryngeal edema, Stevens-Johnson syndrome, etc.); 2. Participants with other malignant tumors: Those with concurrent or past history of other malignant tumors, except for the following cases: cured basal cell carcinoma of the skin for =5 years with no evidence of recurrence; cervical carcinoma in situ or other in situ carcinomas treated with standard therapy and no residual lesions; participants with tumor history that may affect the assessment of survival outcomes should also be excluded; 3. Participants with severe underlying diseases or impaired functions of major organs: Those with any of the following conditions: severe cardiovascular diseases (e.g., unstable angina, recent myocardial infarction, stroke, etc.); liver dysfunction (e.g., ALT/AST =2.5 times the upper limit of normal, or Child-Pugh class C); renal insufficiency (eGFR <30 mL/min/1.73m²); coagulation disorders or active bleeding tendencies; participants deemed unsuitable for receiving the investigational treatment or who may affect safety assessments by the investigator; 4. Pregnant or breastfeeding women: Pregnant or breastfeeding women; women of childbearing potential who are unwilling or unable to use effective contraceptive measures; women planning pregnancy during the study period; 5. Participants involved in other clinical studies: Those currently participating in or who participated in other drug or interventional clinical studies within 3 months prior to enrollment and have not completed follow-up; those who may interfere with the primary endpoint or safety evaluation of this study; 6. Participants with mental or cognitive impairments: Patients with severe mental illnesses (e.g., schizophrenia, major depressive disorder with psychotic symptoms, etc.); those with significant cognitive impairments, communication difficulties, inability to understand the study content, sign informed consent, or complete questionnaire assessments; those with poor compliance deemed unable to complete treatment and follow-up according to the protocol by the investigator; 7. Participants with severe skin damage or infections: Those with severe skin reactions after radiotherapy or chemotherapy, including but not limited to: active purulent infections; ulcers reaching the dermis or deeper tissues; localized or widespread skin necrosis; those deemed by the investigator to have no short-term recovery, which may affect the safety or efficacy evaluation of the investigational drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Significant improvement rate of TCM syndromes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-Free Survival (DFS);Distant metastasis-free survival (MFS);Overall Survival/OS;Recurrence/Metastasis Patterns and Timing;Outcomes of skin damage associated with radiotherapy and chemotherapy;Psychological outcome;Patient-Reported Outcomes (PRO);Safety Index; | — |
Countries
China
Contacts
Public ContactLiu Zhuo, Yi Xin Ying
Hunan Province Integrated Chinese and Western Medicine Hospital
Outcome results
None listed