Chemotherapy-induced peripheral neuropathy
Conditions
Interventions
Pregabalin-Bortezomib treatment group:Administer Pregabalin 150mg orally twice a day during chemotherapy.
Placebo-Bortezomib treatment group:Placebo (empty capsule + sugar powder)
Sponsors
The First Affiliated Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: (1) Age > 18 years, regardless of gender, with an expected lifespan of more than 6 months. (2) Clearly and newly diagnosed with multiple myeloma and requiring bortezomib treatment. (3) Absence of neuropathic pain in any part of the body. (4) No anti-neuropathic pain treatment of any form within the past month. (5) Voluntary participation in this study, with signed informed consent. (6) During the trial period, no drugs or treatments unrelated to the experiment will be received.
Exclusion criteria
Exclusion criteria: (1) Those who have objections to the treatment methods used in this experiment. (2) Suffering from severe systemic diseases. (3) Renal insufficiency (creatinine clearance rate less than 60 mL/min). (4) Use of anti-neuropathic pain medications such as pregabalin, gabapentin, or carbamazepine within the past month. (5) Severe psychiatric disorders or other conditions that prevent independent pain scoring or objective description of symptoms. (6) Inability to follow up as scheduled. (7) Allergy to any drugs used in the treatment process. (8) Concurrent diseases that may cause peripheral neuropathy. (9) Patients with tumors of any type or location. (10) Patients with severe spinal diseases or symptoms of limb numbness and pain caused by cerebral infarction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Chemotherapy-Induced Peripheral Neuropathy (CIPN) after Completion of Phase I Chemotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Completion Rate of Chemotherapy with Bortezomib;Visual Analogue Scale / Score, VAS;Grading of Chemotherapy-Induced Peripheral Neuropathy (CIPN Grading);Opioid Consumption;SF-12; | — |
Countries
China
Contacts
Public ContactDaosong Dong
The First Affiliated Hospital of China Medical University
Outcome results
None listed