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Prevention of Chemotherapy Induced Neuropathy

Efficacy of Gabapentin for the Prevention of Paclitaxel Induced Peripheral Neuropathy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017021132494N1
Enrollment
40
Registered
2017-04-30
Start date
2010-07-31
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

chemotherapy induced neuropathy. Other antineoplastic drugs

Interventions

Intervention 1: in intervention group Gabapentin is prescribed 300mg orally for the first day, 300mg every 12 hour for the second day and 300mg every 8 hour for the third to fourteenth day of each ch
Treatment - Drugs
in intervention group Gabapentin is prescribed 300mg orally for the first day, 300mg every 12 hour for the second day and 300mg every 8 hour for the third to fourteenth day of each chemotherapy cycle
in control group placebo is prescribed orally one capsule for the first day, one capsule every 12 hour for the second day, one capsule every 8 hour for the third to fourteens day of chemotherapy.

Sponsors

Bakhtar Bioshimi Company
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria : Women who have pathologically confirmed non metatstatic breast cancer; aged 18-65; candidate for receiving 4 course of paclitaxel ; good performance status (based on Karnofsky Score) Exclusion criteria : history of diabetes mellitus; previous neuropathy; chronic renal or liver disease; consumption of neurotoxic/neurotropic/neuroleptic drugs

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Taxane induced neuropathy. Timepoint: befor and after each chemotherapy session. Method of measurement: taking history and physical exam.

Secondary

MeasureTime frame
Objective neuropathy. Timepoint: befor begining chemotherapy session and 6 week after last chemotherapy session. Method of measurement: nerve conducting study.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNima Mousavi Darzikolaee

Radiation Oncology Research Center, Cancer Institute , Imam Khomeini Hospital Complex

mousavi-n@razi.tums.ac.ir+98 21 6694 8679

Outcome results

None listed

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