A prospective study to evaluate the efficacy and safety of pregabalin for triweekly abraxane-induced peripheral neuralgia

A prospective study to evaluate the efficacy and safety of pregabalin for triweekly abraxane-induced peripheral neuralgia - Pregabalin for abraxane-induced peripheral neuralgia

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006987

Enrollment

Registered

2011-12-29

Start date

2011-12-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Breast cancer

Interventions

Pregabalin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who received abraxane for breast cancer and suffer from more than grade 2 peripheral neuralgia 2. Patients with no peripheral neuropathy caused by diabetes and other disease 3. 20 years old or more 4. Possible oral intake 5. Estimated life expectancy of at least 6 months 6. Signed informed consent

Exclusion criteria

Exclusion criteria: 1. Contraindication to abraxane and pregabalin 2. Creatinine clearance less than 30mL/min 3. With previous history of pregabalin administration 4. With unstable dosage of antidepressant drugs at 3 weeks of registration 5. With serious drug allergy 6. With severe complications 7. Pregnant or nursing women 8. With peripheral neuropathy caused by other drugs 9. Determination as contraindication by doctors

Design outcomes

Primary

Measure	Time frame
The rate of patients which PNQ score improved after administration of pregabalin	—

Secondary

Measure	Time frame
The rate of patients which SF-MPQ score improved after administration of pregabalin The rate of patients which VAS score improved by more than 50% after administration of pregabalin The rate of patients which NCI-CTCAE grade improved after administration of pregabalin The number of courses in which peripheral neuropathy occurred The site of onset of peripheral neuropathy Safety The number of treatment courses Time to improvement in patients who developed grade 3 peripheral neuropathy	—

Measure

Time frame

The rate of patients which SF-MPQ score improved after administration of pregabalin The rate of patients which VAS score improved by more than 50% after administration of pregabalin The rate of patients which NCI-CTCAE grade improved after administration of pregabalin The number of courses in which peripheral neuropathy occurred The site of onset of peripheral neuropathy Safety The number of treatment courses Time to improvement in patients who developed grade 3 peripheral neuropathy

—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026