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A pilot study to evaluate the efficacy of lafutidine in patients with paclitaxel-induced peripheral neuropathy.

A pilot study to evaluate the efficacy of lafutidine in patients with paclitaxel-induced peripheral neuropathy. - A pilot study to evaluate the efficacy of lafutidine in patients with paclitaxel-induced peripheral neuropathy.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011890
Enrollment
30
Registered
2013-09-27
Start date
2013-07-01
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

gynecological cancer

Interventions

Lafutidine is administered orally twice daily at a dose of 10 mg for 12 weeks.

Sponsors

Fukushima medical University Hospital, School of medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: (1) Gynecological cancer patients with paclitaxel-induced peripheral neuropathy (>=Grade1). (2) Patients with gastric or esophageal lesion. (gastric ulcer or reflux esophagitis.) (3) Age of 20 years or older. (4) ECOG Performance Status (PS) of 0 - 2. (5) Sufficient oral intake. (6) Written informed consent.

Exclusion criteria

Exclusion criteria: (1) Current use of other anti-ulcer drugs. (2) Pregnant females and nursing mothers. (3) With history of severe drug allergies. (4) Physician concludes that the patient's participation in this trial is inappropriate.

Design outcomes

Primary

MeasureTime frame
Short-form McGill Pain Questionnaire(SFMPQ) Patient Neurotoxity Questionnaire(PNQ)

Secondary

MeasureTime frame
Peripheral neuropathy evaluated by CTCAE v4.02 Adverse drug reaction of lafutidine

Countries

Japan

Contacts

Public ContactShigenori Furukawa

Fukushima Medical University, School of medicine Department of Obstetrics and Gynecology

s-furu@infoseek.jp024-547-1111

Outcome results

None listed

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