Efficacy and safety of hydroxocobalamin acetate in patients with taxane-induced sensory peripheral neuropathy A multi-center, observational study(HAPPY study)

Efficacy and safety of hydroxocobalamin acetate in patients with taxane-induced sensory peripheral neuropathy A multi-center, observational study(HAPPY study) - HAPPY study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000022292

Enrollment

Registered

2016-05-13

Start date

2016-05-13

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

sensory peripheral neuropathy

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Breast cancer is diagnosed histologically 2) A cancer is announced 3) An operation, the treatment by radiation are not planned during a study period 4) I have peripheral neuropathy (more than CTCAE Grade1) by the chemotherapy including of the past or taxane drugs taking effect now 5) The dosage of the hydroxocobalamin note is planned 6) Survival more than one month is expected 7) An answer is allowed by a question paper 8) The medical attendant judges that study entry is possible

Exclusion criteria

Exclusion criteria: 1) There is the history of treatment by other peripheral neuropathy-related anticancer agents

Design outcomes

Primary

Measure	Time frame
NRS	—

Secondary

Measure	Time frame
NRS, FACT/GOG-NTX-12, Adverse event	—

Countries

Japan

Contacts

Public ContactHiroto Ishiki

Research hospital, the Institute of Medical Science,the University of Tokyo Department of Palliative Oncology

ishiki-tky@umin.ac.jp03-3443-8111

Outcome results