臨床研究等提出・公開システム

Exploration of the effects of cognitive training on maintaining and improving cognitive function during adjuvant chemotherapy for breast cancer and its underlying mechanisms.

Effects of cognitive training on chemotherapy-related cognitive impairment in breast cancer Ppatients and the underlying mechanisms.

Miyashita Mika

Kyoto University

53 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto City, Kyoto

miyashita.mika.3w@kyoto-u.ac.jp

Miyashita Mika

Kyoto University

53 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto City, Kyoto

+81-75-751-3921

miyashita.mika.3w@kyoto-u.ac.jp

Recruiting

July. 23, 2026

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

single assignment

other

1. Women diagnosed with Stage I-III breast cancer.
2. >/=18 years old, <75 years old.
3. Undergoing neoadjuvant or adjuvant chemotherapy for breast cancer (regardless of whether or not they have hormonal therapy or anti-HER-2 therapy).
4. Able to carry in and set up cognitive training equipment (pedals, etc.) at home by themselves or with a family member.
5. Received and understood an explanation of the disease and treatment.
6. Able to speak, read, and write in Japanese.

1. recurrence or metastasis
2. Difficulty in participating in cognitive training due to after-effects of surgery for breast cancer (e.g., limited range of motion in the shoulders or arms, pain) and adverse events of treatment (e.g., fatigue, peripheral neuropathy).
3. Mental health problems (diagnosis or history of depression, adjustment disorder, etc.), or in need of mental treatment as determined by the physician or psychiatrist.
4. Cardiac or respiratory disease requiring follow-up or treatment.
5. Cognitive problems caused by central nervous system disorders
6. Central nervous system or orthopedic disease that interferes with pedaling ability.
7. History of radiation therapy to the central nervous system.
8. History of chemotherapy for cancer.
9. For any other reason determined by the principal investigator to be unable to participate in the study.

Female

Breast Cancer

Cognitive training combining games and exercise will be performed at least three times a week (if possible) during chemotherapy.

Breast Cancer

Cognitive Training

Breast Neoplasm

1. Functional Assessment of Cancer Therapy-Cognitive Function Version 3 Japanese version (FACT-Cog)

1. The Trail Making Test (TMT) Parts A and B Japanese version
2.Proinflammatory cytokines, Anti-inflammatory cytokines, brain derived neurotrophic factor (BDNF), insulin-like growth factor 1 (IGF-1), fibroblast growth factor 2 (FGF-2), vascular endothelial growth factor A (VEGF-A)
3. Functional Assessment of Chronic Illness Therapy-Fatigue ver.4 Japanese version (FACIT-Fatigue)
4. Pittsburgh Sleep Quality Index
5. Profile of Mood States 2nd Edition Japanese version Adult (POMS 2) Short version

+81-75-366-7618

Jan. 30, 2026

Yes

When anonymized data is saved, a password will be set to prevent access by anyone other than the principal investigator and co-researchers. The data will be stored in an electronic medical record environment and shared by the principal investigator and co-researchers.

none