Chemotherapy-induced peripheral neuropathy
Conditions
Interventions
Control group:For patients using paclitaxel or oxaliplatin regimens for the first time, take a placebo starting the day before each chemotherapy session, 4 tablets at a time, 3 times a day, take for 2
Research group:For patients using paclitaxel and oxaliplatin regimen for the first time, take saffron glycoside tablets starting the day before each chemotherapy session, 4 tablets at a time, 3 times
Sponsors
The First Affiliated Hospital of Dalian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with confirmed diagnosis of solid tumors such as lung cancer, breast cancer, gastrointestinal tumors, or gynecological tumors based on 2019 NCCN guidelines combined with imaging and pathological examinations; 2. Age between 18 and 80 years, generally in good physical condition (ECOG score: =2), with an estimated survival period of =6 months and no contraindications to chemotherapy; 3. Patients receiving first-line chemotherapy with paclitaxel or oxaliplatin regimens; 4. Normal nerve conduction velocity in both lower limbs; 5. No language communication impairment, and the study participants can accurately understand the questionnaire content; 6. Consent to participate in the study, cooperate with visits, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. History of neurological disorders, peripheral neuropathy, or family history of hereditary peripheral neuropathy. 2. Patients with malignant brain metastases or spinal metastases that may present with neurological symptoms. 3. Peripheral neuropathy induced by radiotherapy, trauma, or other physical, chemical, or biological factors. 4.3 Patients who have taken neurotoxic drugs such as metronidazole, colchicine, sulfasalazine, tacrolimus, nucleoside analogs, hydralazine, or disulfiram within the past 3 months and have experienced neurotoxic reactions. 5. Any chemotherapy regimen with neurotoxicity potential used within the past 1 month, or consumption of traditional Chinese medicine (TCM) or Chinese patent medicines containing saffron within 2 weeks prior to enrollment. 6. Poor compliance, or inability to comprehend the scale content despite repeated explanations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nerve conduction velocity in both lower extremities;The degree and incidence of CIPN; | — |
Secondary
| Measure | Time frame |
|---|---|
| Inflammatory indicators(TNF-a, IL-6, IL-10, SII, etc.);Quality of life; | — |
Countries
China
Contacts
Public ContactFengqi Fang
The First Affiliated Hospital of Dalian Medical University
Outcome results
None listed