CTRI/2022/02/040030
Active, not recruiting
Phase 3
Randomized double-blind, placebo-controlled study of oral gabapentin for prevention of sensory neuropathy in patients receiving paclitaxel
Dr Atul Batra0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: C50- Malignant neoplasm of breastHealth Condition 2: C51-C58- Malignant neoplasms of female genital organsHealth Condition 3: C30-C39- Malignant neoplasms of respiratory and intrathoracic organs
- Sponsor
- Dr Atul Batra
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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