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A multicenter randomized controlled clinical study on the treatment of peripheral neurotoxicity caused by albumin-bound paclitaxel with modified Huangqi Guizhi Wuwu Decoction combined with four extremity bloodletting

A multicenter randomized controlled clinical study on the treatment of peripheral neurotoxicity caused by albumin-bound paclitaxel with modified Huangqi Guizhi Wuwu Decoction combined with four extremity bloodletting

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001281
Enrollment
Unknown
Registered
2025-06-26
Start date
2025-07-10
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

lung cancer

Interventions

Treatment group:Modified Huangqi Guizhi Wujufu Decoction combined with foot and hand bloodletting
Control group:mecobalamin tablet

Sponsors

Shanxi Provincial Academy of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Patients whose lung cancer has been confirmed by pathology or cytology; 2) Patients aged 18-80 years old, with no gender restrictions; 3) Patients with KPS score = 60 and expected survival period of no less than 3 months; 4) Patients who developed peripheral neuropathy after receiving paclitaxel (albumin-bound) treatment; 5) Patients without major organ dysfunction of the major systems and without cardiovascular or cerebrovascular complications; 6) All four limbs' skin is intact; 7) Patients who can understand the situation of this study, voluntarily accept traditional Chinese medicine treatment, and have good compliance with questionnaire survey.

Exclusion criteria

Exclusion criteria: 1) Patients with platelet count lower than 60×109/L or prothrombin time greater than 16 seconds who are prone to bleeding; 2) Patients with symptoms related to nerve compression caused by brain metastasis, or peripheral nerve damage due to tumor compression; 3) Patients with previous peripheral neuropathy, such as neurological diseases, orthopedic-related diseases, or peripheral nerve damage caused by circulatory disorders; 4) Patients with a history of drug contact allergy or with skin lesions on hands and feet (such as eczema); 5) Patients who cannot cooperate with treatment; 6) Pregnant or lactating women; 7) Patients who have participated in other clinical trials currently or within 4 weeks; 8) Patients with allergic constitution and prone to drug allergy.

Design outcomes

Primary

MeasureTime frame
EORTCQLQ-CIPN20;

Secondary

MeasureTime frame
Psychological State Rating Scale;NCI-CTCAE V5.0;FACT/GOG-Ntx subscale;Traditional Chinese Medicine Syndrome Score;VAS score;

Countries

ZHONGGUO

Contacts

Public ContactLi Xiaoli

Shanxi Provincial Academy of Traditional Chinese Medicine

fangliaokelixiaoli@163.com13133000182

Outcome results

None listed

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