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WJOG18123B: Randomized placebo-controlled study of S-equol containing supplement for the control of aromatase inhibitor-induced musculoskeletal pain and stiffness in hands
(SAKURA)

Study of S-equol containing supplement for the control of AIMSS (SAKURA)

Terata Kaori

Akita University Hospital

44-2 Hasunuma Hiroomote, Akita-shi, Japan

trt0605@yahoo.co.jp

Terata Kaori

Akita University Hospital

44-2 Hasunuma Hiroomote, Akita-shi, Japan

+81-18-884-6132

trt0605@yahoo.co.jp

Recruiting

Mar. 28, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

Primary enrollment
1) Histologically diagnosed invasive breast cancer
2) Pathological stage I or II
3) Confirmed menopause
4) Hormone receptor positive
5) Currently receiving a standard dose of a third-generation aromatase inhibitor as postoperative adjuvant therapy for at least 21 days prior to primary enrollment, with at least 180 days of treatment planned after primary enrollment
6) Symptoms of arthralgia or stiffness in the fingers develop or worsen after initiation of aromatase inhibitor therapy.
7) Radiotherapy, if any, completed at least 28 days prior to primary enrollment
8) Recovering from adverse effects of surgery, radiation therapy, or chemotherapy
9) Female, 18 years of age or older
10) ECOG performance status of 0 to 1
11) Self-administered Equol production test and symptom assessment
12) Able to enter ePRO
13) No severe impairment of major organs and meet the criteria
14) Patients have been fully informed of the study and have given their written consent prior to enrollment in the study.
Secondary Enrollment
1) Non-producers of Equol
2) QuickDASH score of 15 or higher on the day of enrollment after primary enrollment
3) Secondary enrollment date is 21 days after the primary enrollment date (+14 days allowed)

Primary enrollment
1) Patients with local or systemic active infection requiring medical treatment
2) Patients who are breastfeeding or unwillingness to use contraception
3) Clinically problematic psychiatric disorders that would preclude enrollment in the study
4) Receiving continuous systemic administration of steroids or immunosuppressant
5) Has osteoarthritis of the fingers
6) Is under treatment for inflammatory, metabolic (e.g., thyroid dysfunction), or neurogenic arthropathy
7) Is being treated for collagen disease
8) Had a hand or knee fracture or hand or knee surgery within 6 months prior to primary enrollment
9) Had diarrhea symptoms (PRO-CTCAE: loose or watery stools) within 7 days prior to primary enrollment
10) Currently receiving prescribed drugs
11) Currently taking or have previously taken supplements containing Equol
12) Has a soy allergy
13) Other cases deemed inappropriate by the physician
Secondary enrollment
No exclusion criteria

Female

Aromatase inhibitor-induced musculoskeletal pain and stiffness (AIMSS) in hands

S-equol containing supplement (Equelle petit)
Placebo

S-equol containing supplement (Equelle petit)

Improves function, pain and stiffness in the hands according to the Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH).

1. Improves function, pain and stiffness in the hands according to the M-SACRAH of each 3 parts and of the VAS of each 12 items.
2. Improves function, pain and stiffness in the hands according to the Quick DASH score
3. Improves functional quality of life as measured by the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES).
4. Improves joint pain in the hands according to the number of joins with pain.
5. Status for analgesic use.
6. Safety.
7. Duration for AI therapy.

+81-3-3784-8129

Jan. 23, 2025

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