Health Condition 1: C50- Malignant neoplasm of breast Health Condition 2: C51-C58- Malignant neoplasms of female genital organs Health Condition 3: C30-C39- Malignant neoplasms of respiratory and intrathoracic organs
Conditions
Interventions
Intervention1: Gabapentin: Oral Tablet Gabapentin
300mg once daily at night time
For 18 weeks
Control Intervention1: Placebo tablets: Matched placebo tablets with same shape, color, and ingredients
Sponsors
Dr Atul Batra
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of CTCAE v5.0 grade 2 or higher chemotherapy induced sensory neuropathyTimepoint: 3 months after last chemotherapy cycle or onset of symptoms (Whichever is earlier) | — |
Secondary
| Measure | Time frame |
|---|---|
| Impact of Gabapentin therapy on daily work related and personal activities (Self-reported)Timepoint: From recruitment till 3 months after last chemotherapy cycle;Nerve conduction velosity changeTimepoint: Baseline, three months on therapy, and three months after last chemotherapy cycle;Patient-reported outcomes (EORTC QLQ-CIPN20)Timepoint: 3 months after last chemotherapy cycle or onset of symptoms (Whichever is earlier);Preventing all grades of neuropathy (NCI CTCAE v5.0)Timepoint: 3 months after last chemotherapy cycle or onset of symptoms (Whichever is earlier);Proportion of patients with dose modification in paclitaxel therapy because of chemotherapy induced sensory neuropathyTimepoint: Till last cycle of chemotherapy;Safety profile of oral gabapentin for this indicationTimepoint: 3 months after last chemotherapy cycle;Self reported adherence to therapyTimepoint: 3 months after last chemotherapy cycle or onset of symptoms (Whichever is earlier);Time to develop clinically detectable neuropathyTimepoint: 3 months after last chemotherapy cycle or onset of symptoms (Whichever is earlier) | — |
Countries
India
Contacts
Public ContactPraful Pandey
All India Institute of Medical sciences, New Dehi
Outcome results
None listed