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Effect and safety of pregabalin and duloxetine on chemotherapy-related peripheral neurotoxicity for patients with advanced gastric and breast cancer.

Effect and safety of pregabalin and duloxetine on chemotherapy-related peripheral neurotoxicity for patients with advanced gastric and breast cancer. - Effect and safety of pregabalin and duloxetine on chemotherapy-related peripheral neurotoxicity for patients with advanced gastric and breast cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000015872
Enrollment
60
Registered
2014-12-08
Start date
2014-11-10
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

Gastric cancer, breast cancer

Interventions

Pregabalin is administered 75mg bid and increased gradually 150mg bid over 1week. Duloxetine is administered 40mg qd. To begin administering 20mg qd, duloxetine is increased 40mg qd after an interval

Sponsors

Osaka Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who have diagnosed gastric or breast cancer by cytodiagnosis or histological diagnosis. 2) Patients who have chemotherapy -related neurotoxicity (Grade2:CTCAE v4.0) and pain. 3) ECOG PS of 0 or 1 4) Adequate function of vital organs 5) Satisfactory oral feeding 6) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Serious drug allergy 2) Active double cancer 3) Active infection 4) Serious coexisting illness 5) History of pregabalin and duloxetine treatment 6) Severe renal dysfunction (Creatinine clearance <30mL/min) 7) Patients with using electronic implants or other cardiac pacemaker 8) Pregnant or lactating women or men who have desire father a child 9) Investigator's judgement

Design outcomes

Primary

MeasureTime frame
Proportion of patients who was improved FACT-Taxane after administering pregabalin or duloxetine.

Secondary

MeasureTime frame
1) Adverse effect of pregabalin and duloxetine 2) Investigation of QOL (FACT-Taxane) 3)Current perception threshold(CPT)

Countries

Japan

Contacts

Public ContactMasashiro Goto

Osaka Medical College Hospital Chemotherapy Center

in2030@poh.osaka-med.ac.jp072-683-1221

Outcome results

None listed

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