Medicine to prevent chemotherapy complicatio

Phase 3

• 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

• Registration Number: CTRI/2022/02/040030
• Lead Sponsor: Dr Atul Batra

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)