Aromatase inhibitor-induced musculoskeletal pain and stiffness (AIMSS) in hands
Conditions
Interventions
S-equol containing supplement (Equelle petit)
Placebo
Sponsors
Yamamoto Nobuyuki
Imamura Chiyo
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactKaori Terata
Akita University Hospital
Outcome results
None listed