Unique ID issued by UMIN | UMIN000004416 |
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Receipt number | R000005255 |
Scientific Title | Japanese study for usefulness of vitamin E in reducing aromatase inhibitor-associated joint symptoms |
Date of disclosure of the study information | 2010/11/01 |
Last modified on | 2016/01/24 19:22:04 |
Japanese study for usefulness of vitamin E in reducing aromatase inhibitor-associated joint symptoms
Japanese study for usefulness of vitamin E in reducing aromatase inhibitor-associated joint symptoms (Juvera trial)
Japanese study for usefulness of vitamin E in reducing aromatase inhibitor-associated joint symptoms
Japanese study for usefulness of vitamin E in reducing aromatase inhibitor-associated joint symptoms (Juvera trial)
Japan |
Breast cancer
Breast surgery |
Malignancy
NO
To investigate safety and efficacy of vitamin E in alleviating aromatase inhibitor-associated joint symptom
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
Serum concentration of estrogen
Efficacy for joint symptom, adverse event, serum concentration of vitamin E and IL-6
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Medication of vitamin E
50 | years-old | <= |
Not applicable |
Female
Postmenopausal breast cancer patients who are aged 50 and over, received surgery and/or adjuvant chemotherapy and/or postsurgical radiotherapy, and currently taking a aromatase inhibitor as adjuvant hormone therapy
Patients who report CTC Grade 2 or 3 arthralgia after initiation of aromatase inhibitor therapy
Patients whose written informed consent are available
Patients who are suffering bone or joint disease, such as rheumatoid arthritis, osteoarthritis deformans, frozen shoulder syndrome, severe osteoporosis etc.
Previous history of neurological disorder
Recurrent breast cancer cases
Vitamin E users as supplement
Patients who are taking a anticoagulant or are expected surgery
80
1st name | |
Middle name | |
Last name | Masujiro Makita |
Cancer Institute Hospital Breast Cente
Breast Oncology
3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan
03-3520-0111
1st name | |
Middle name | |
Last name | Masujiro Makita |
Cancer Institute Hospital Breast Center
Breast Oncology
mmakita@jfcr.or.jp
Cancer Institute Hospital Breast Center
None
Self funding
Tokyo University of Pharmacy and Life Sciences, Department of Clinical Pharmacology
NO
2010 | Year | 11 | Month | 01 | Day |
Published
The osteoarthropathy scores significantly decreased after vitamin E administration (p=0.0243), while serum-estradiol concentrations did not change. The serum-estradiol concentrations before vitamin E administration in the group sensitive to the vitamin E efficacy were significantly lower, as compared with those in the insensitive group (p=0.0005).
J Cancer 6(4): 367-376. 2015
Completed
2010 | Year | 10 | Month | 06 | Day |
2010 | Year | 11 | Month | 01 | Day |
2010 | Year | 10 | Month | 19 | Day |
2016 | Year | 01 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005255
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