The effect of safflower extract and aceglutamide injection on preventing chemobrain: a multicenter, randomised controlled, phase II trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IIR-16009298

Enrollment

Unknown

Registered

2016-09-30

Start date

2016-09-14

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Breast cancer/lung cancer/ovarian cancer

Interventions

Experimental: Arm A:safflower extract and aceglutamide injection 20ml+DP (docetaxel 75mg/m2+cisplatin (75mg/m2)/carboplatin (AUC=5), Breast cancer: TAC(docetaxel:75mg/m2+epirubicin50mg/m2+CTX500mg/m2

Placebo Comparator: Arm B:normal saline 20ml+DP (docetaxel75mg/m2+cisplatin (75mg/m2)/carboplatin (AUC=5), Breast cancer:TAC (docetaxel:75mg/m2+epirubicin50mg/m2+CTX500mg/m2))

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients must have Histologically or cytologically confirmed non small cell carcinoma, ovarian cancer, and are previously untreated with chemotherapy; 2. Patient must have measurable stage IIIB (contralateral hilar lymph node metastases)/ IV disease (includes M1a, M1b stages or recurrent disease). However, patients with brain metastasis are not eligible; 3. Aged from 18 to 70 years old; both male and female; 4. Patients must have a Life Expectancy of greater than 12 weeks; 5. Functions of major organs (haemogram,heart, liver, kidney) are basically normal, White blood count =3.5 x 109/L with neutrophils =1.5 x 10^9/L, platelet count=100 x 10^9/L, and hemoglobin =90g/L. Total bilirubin =1.5 times upper limit of normal (ULN) range; alkaline phosphatase(ALP)= 2.5 times ULN, Transaminases AST (SGOT) and ALT (SGPT) = 2.5 times ULN, serum creatinine = 1.2 times ULN); 6. With ECOG performance status 0-2; 7. Patients must have the ability to understand and the willingness to sign a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Any evidence of severe or uncontrolled systemic diseases (e.g., unstable respiratory, cardiac, hepatic, or renal disease or other serious internal diseases or uncontrolled infection; 2. Women that are pregnant or breastfeeding; 3. Known severe hypersensitivity to docetaxel and, cisplatin/carboplatin and safflower extract and aceglutamide injection.

Design outcomes

Primary

Measure	Time frame
cognitive status;brain connectivity;	—

Countries

China

Contacts

Public ContactChuying Huang

Enshi Tujia and Miao Autonomous Prefecture Central Hospital

724249691@qq.com+86 15027234433

Outcome results

None listed

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