Study on the search for factors, including Kampo medicine treatment, that affect adverse symptoms associated with endocrine therapy and work activity in breast cancer patients.

Prospective observational study on the search for factors, including Kampo medicine treatment, that affect adverse symptoms associated with endocrine therapy and work activity in breast cancer patients. - Prospective observational study on the search for factors, including Kampo medicine treatment, that affect adverse symptoms associated with endocrine therapy and work activity in breast cancer patients.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000054353

Enrollment

160

Registered

2024-05-09

Start date

2024-05-01

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

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: (1) Disease: First-episode breast cancer (2) Clinical stage: Stage 0 to Stage III (according to the following classification) (3) Age: 20 years of age or older at the time of consent (4) Gender: Female (5) The patient is undergoing endocrine therapy for breast cancer (more than 28 days after the start of endocrine therapy) and has not been prescribed any Chinese herbal medicine for side effects of endocrine therapy for breast cancer (6) Having adverse symptoms (vasomotor ataxia, physical symptoms, psychiatric symptoms) after endocrine therapy for breast cancer (over 4 for at least one symptom on NRS 0-10) (7) Performance status (ECOG scale) of 0 or 1 (8) Have obtained written consent to participate in the study (9) Able to input data via the Internet from a device such as a PC, tablet, or smartphone.

Exclusion criteria

Exclusion criteria: (1) Have a serious concomitant disease (liver disease: cirrhosis, renal disease: on dialysis, cardiac disease: chronic heart failure, hematological disease: leukemia, or metabolic disease: poorly controlled diabetes, etc.) (2) Women who are pregnant, may become pregnant (only if they wish to become pregnant during the study period), or are breastfeeding (3) Have concurrent overlapping cancers (4) Any other cases in which the principal investigator or subinvestigator determines that the subject is inappropriate as a research subject.

Design outcomes

Primary

Measure	Time frame
subjective symptoms	—

Secondary

Measure	Time frame
EQ-5D-5L WPAI-GH FACT-B	—

Countries

Japan

Contacts

Public ContactShin Takayama

Tohoku University Hospital Department of Education and Support for Regional Medicine

takayama@med.tohoku.ac.jp0227177507

Outcome results