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A Prospective, Randomized, Double-Blind, Placebo-Controlled Parallel Study of Ginkgo Biloba Extract Tablets in Preventing Chemotherapy-Induced Cognitive Impairment in Breast Cancer Patients

A Prospective, Randomized, Double-Blind, Placebo-Controlled Parallel Study of Ginkgo Biloba Extract Tablets in Preventing Chemotherapy-Induced Cognitive Impairment in Breast Cancer Patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000440
Enrollment
Unknown
Registered
2026-03-03
Start date
2025-12-20
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Chemotherapy Related Cognitive Impairment

Interventions

Experimental Group:Ginkgo biloba extract tablets, three times daily, one tablet each time, orally, plus chemotherapy/follow-up.
Control Group:Ginkgo Ketone Ester Placebo, 3 times daily, 1 tablet each time, oral administration + chemotherapy/follow-up

Sponsors

Shanghai University of Traditional Chinese Medicine Affiliated Longhua Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1)Pathological examination confirmed the diagnosis of breast cancer, with pathological staging at I~III; 2) Postoperative patients who initially received anthracycline-containing chemotherapy according to standard protocols and dosages, without recurrence, metastasis, or intracranial abnormalities; 3) Normal general cognitive function, basically normal activities of daily living, no functional impairments in hearing, vision, or language, and a Karnofsky score =60; 4) Female patients aged 18-65 years (including 18 and 65 years); 5) Willing to undergo treatment, observation, and all required examinations.

Exclusion criteria

Exclusion criteria: 1. Patients with severe anxiety, depression, and schizophrenia; 2. Patients with an estimated life expectancy of less than 6 months; 3. Patients with severe primary diseases of the cardiovascular, liver, kidney, or hematopoietic systems; 4. Nursing mothers, pregnant women, or those planning to become pregnant; 5. Individuals with a history of alcohol or substance dependence, or those taking medications that improve cerebral circulation, brain metabolism, or neuroprotective agents that may affect cognitive function; 6. Individuals with an allergic constitution who are allergic to Ginkgo biloba extract.

Design outcomes

Primary

MeasureTime frame
Chemotherapy-Induced Cognitive Impairment Incidence Rate;

Secondary

MeasureTime frame
Memory Assessment;Attention Function Assessment;Executive Function Assessment;Anxiety ;Depression;Sleep quality;Functional Assessment - Cognitive Function;Traditional Chinese Medicine Symptom Evaluation;Subjective Cognitive Evaluation;

Countries

China

Contacts

Public ContactSun Chenping

Shanghai University of Traditional Chinese Medicine Affiliated Longhua Hospital

scptcm@126.com18001667612

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Apr 4, 2026