Randomized double-blind, placebo-controlled study of oral gabapentin for prevention of sensory neuropathy in patients receiving paclitaxel

Dr Atul Batra0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年1月22日

试验速览

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•2. Starting Paclitaxel for breast, lung, and gynaecological malignancies, either in adjuvant or neoadjuvant setting
•3. Patients planned for atleast 4 or more cycles of paclitaxel therapy of atleast 75% of the recommended dose
•a) Ovarian cancer: 135 – 175mg/m2 every 3 weeks
•b) Breast cancer: 175mg/m2 every 2 or 3 weeks
•c) Cervical cancer/ Uterine cancer: 175mg/m2 every 3 weeks
•d) Lung cancer: 175 – 200mg/m2 every 3 weeks
•e) Weekly schedule: 60 – 80mg/m2 every week
•4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
•5. Able to start study treatment within 14 days of randomization
•6. Willing and able to comply with all study requirements, including treatment (daily gabapentin therapy), timing and/or nature of required assessments

•1.Any evidence of sensory neuropathy on clinical examination or nerve conduction studies
•2.Prior therapy with taxanes
•3.Other conditions that in the opinion of the physician may neurocognitive function or may complicate evaluation during study treatment
•4.Concurrent or planned use of agents known to relieve neuropathic symptoms (Example: Tricyclic anti-depressants, Pregabalin, Duloxetine, etc.)
•5.Any therapy with tricyclic anti-depressants, pregabalin, duloxetine, or gabapentin within the last one month prior to enrollment
•6.Allergic or anaphylactic reactions with Gabapentin
•7.Patients receiving oral Gabapentin for other conditions
•8.Concurrent illnesses, including severe infections that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
•9.Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
•10.Pregnant or lactating women

发起方

Dr Atul Batra