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Study on the efficacy mechanism of Fangxia Dihuang Tang in intervening in breast cancer chemotherapy-related anxiety disorder

Study on the efficacy mechanism of Fangxia Dihuang Tang in intervening in breast cancer chemotherapy-related anxiety disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086667
Enrollment
Unknown
Registered
2024-07-08
Start date
2024-07-15
Completion date
Unknown
Last updated
2024-07-15

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

Conditions

Anxiety disorders associated with chemotherapy for breast cancer

Interventions

Post-operative breast cancer group:(surgical) operation
Breast Cancer Chemotherapy-Related Anxiety Disorder Group:Basic treatment plan: standardized chemotherapy plan (based on the 2023 Chinese Society of Clinical Oncology Breast Cancer Diagnosis and Treat
Breast Cancer Chemotherapy-Related Anxiety Disorder Herbal Intervention Group:Basic Treatment Plan + Fuxia Dihuang Tang

Sponsors

Xiamen Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Female, aged 18-75 years (both 18 and 75 years); (2) Stage I-IIIA breast cancer patients with a clear pathologic diagnosis who received surgical treatment and postoperative chemotherapy; (3) The chemotherapy regimen was the EC regimen (epirubicin + cyclophosphamide); (4) KPS =60 and expected survival =1 year; (5) Patients who received chemotherapy for the first time and entered the maintenance phase with more than stable disease as evaluated by efficacy after 2 cycles of chemotherapy; (6) Patients with anxiety states, 14 points = Hamilton Anxiety Scale (HAMA) < 29 points; (7) Have some ability to understand and express themselves, participate in this study voluntarily, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Use of antibiotics, probiotics or prebiotics as medications or supplements, laxatives, antispasmodics, and antidiarrheals (e.g., orlistat, lactulose), etc., 4 weeks prior to enrollment and during the study period; (2) Combination of amoebic dysentery, chronic inflammatory diseases of the intestinal tract, etc; (3) Acute gastroenteritis within the last 1 week; (4) Accompanied by severe liver disease, kidney disease, autoimmune disease, infectious disease, etc; (5) Smoking, drinking and other bad habits.

Design outcomes

Primary

MeasureTime frame
Resting-state functional magnetic resonance index;Indicators of intestinal flora;Indicators of intestinal metabolites;

Secondary

MeasureTime frame
Whole Blood Transcriptomics Indicators;

Countries

China

Contacts

Public ContactXiao-hua Pei

Xiamen Hospital of Traditional Chinese Medicine

pxh_127@163.com+86 139 1168 3278

Outcome results

None listed

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