Chemotherapy-Induced Myelosuppression in Breast Cancer
Conditions
Interventions
CHM Placebo + Sham Moxibustion Group:Chinese Herbal Medicine Placebo and Sham Moxibustion
Chinese Herbal Medicine (CHM) + Moxibustion Group:Chinese Herbal Medicine and Moxibustion
CHM Placebo + Moxibustion Group:Chinese Herbal Medicine Placebo and Moxibustion
CHM + Sham Moxibustion Group:Chinese Herbal Medicine and Sham Moxibustion
Sponsors
Longhua Hospital Shanghai University of Traditional Chinese Medicine Shanghai China
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)Meet breast cancer diagnostic criteria of both Chinese and Western medicine regardless of tumor stage or molecular subtype;(2)Female aged 18-75 years;(3)Postoperative breast cancer patients eligible for adjuvant chemotherapy with planned completion of 4 cycles of standard chemotherapy (anthracycline-based taxane-based or anthracycline-taxane combination regimens administered every 3 weeks) and consent to receive the specified regimen;(4)Eastern Cooperative Oncology Group (ECOG) performance status score =2;(5)Normal white blood cell and neutrophil counts prior to chemotherapy;(6)Anticipated survival =6 months;(7)No use of myelosuppression prevention/treatment medications within 1 week prior to enrollment;(8)Voluntarily participate and sign informed consent form.
Exclusion criteria
Exclusion criteria: (1)Presence of severe comorbidities in major organs (e.g. serum alanine aminotransferase/aspartate aminotransferase (ALT/AST) >2.5×upper limit of normal (ULN); serum creatinine (Cr) =150 µmol/L);(2)Concurrent hematologic disorders;(3)Metastatic breast cancer or patients who received neoadjuvant therapy;(4)History of other primary malignancies;(5)Pregnancy lactation or planning pregnancy within 6 months;(6)History of substance abuse drug addiction or dependency disorders;(7)Psychiatric or cognitive impairments affecting protocol compliance;(8)Concurrent use of targeted therapy or endocrine therapy during the study period;(9)Documented hypersensitivity to Chinese herbal medicines chemotherapeutic agents or moxibustion;(10)Skin lesions contraindicating moxibustion (e.g. ulcers suppurative lesions active infections at treatment sites);(11)Cutaneous sensory neuropathy or impaired thermal perception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Grade II or Higher Myelosuppression at Week 3 of the Fourth Chemotherapy Cycle; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Traditional Chinese Medicine Syndrome Scores;Change in Quality of Life Questionnaire-Core-30 (QLQ-C30) Scores;Disease-free Survival (DFS);White Blood Cell Count (WBC);Change in Hamilton Anxiety Scale (HAMA) Scores;Absolute Neutrophil Count (ANC);Incidence of Grade II or Higher Myelosuppression at Other Time Points;Medication Use; | — |
Countries
China
Contacts
Public ContactChen Yuelai
Longhua Hospital Shanghai University of Traditional Chinese Medicine Shanghai China
Outcome results
None listed