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A clinical trial to study the effects of two drugs, pregabalin and duloxetine, in patients with chemotherapy-induced peripheral sensory neuropathy.

Efficacy of Pregabalin versus Duloxetine in the Treatment of Chemotherapy Induced Sensory Neuropathy- A Randomized study - Nill

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/069398
Enrollment
60
Registered
2024-06-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G63- Polyneuropathy in diseases classified elsewhere

Interventions

Intervention1: PREGABALIN: Start with per oral tab Pregabalin 50 mg per day, In case of sub-optimal response, increase the dose by 50 mg, every week till 6 weeks, reaching a maximum dose upto 300 mg.

Sponsors

Non sponsored
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Both male and female cancer patients, ages 18 and older, who develop peripheral sensory neuropathy after chemotherapy infusion and are willing to participate in the study, will be included.

Exclusion criteria

Exclusion criteria: Subjects less than 18 years of age, history of any comorbidities like chronic kidney disease, chronic liver disease or if there is any history of drug addiction or substance abuse, will be excluded. Those who fulfil the inclusion criteria but not giving consent to participate in the study will also excluded.

Design outcomes

Primary

MeasureTime frame
The primary outcome measure will be the mean percentage change in NCI CTCAE CIPN grading and VAS pain score, both at 2 weeks and 6 weeks of study.Timepoint: 2 weeks and 6 weeks from the starting point of study.

Secondary

MeasureTime frame
The secondary outcome measure will be calculated by mean percentage change in quality of life score between two groups, which is EORTC QLQ CIPN 20 score, at 6 weeks from the starting point of studyTimepoint: 6 weeks from the study initiation point.

Countries

India

Contacts

Public ContactSushmita Ranga

Sir ganga ram hospital, New Delhi

sushmitaranga7@gmail.com8619042649

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026