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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004416 |
Receipt No. | 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 |
Basic information | ||
Public title | Japanese study for usefulness of vitamin E in reducing aromatase inhibitor-associated joint symptoms | |
Acronym | Japanese study for usefulness of vitamin E in reducing aromatase inhibitor-associated joint symptoms (Juvera trial) | |
Scientific Title | Japanese study for usefulness of vitamin E in reducing aromatase inhibitor-associated joint symptoms | |
Scientific Title:Acronym | Japanese study for usefulness of vitamin E in reducing aromatase inhibitor-associated joint symptoms (Juvera trial) | |
Region |
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Condition | ||
Condition | Breast cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To investigate safety and efficacy of vitamin E in alleviating aromatase inhibitor-associated joint symptom |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | Serum concentration of estrogen |
Key secondary outcomes | Efficacy for joint symptom, adverse event, serum concentration of vitamin E and IL-6 |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Medication of vitamin E | |
Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | 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 |
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Key exclusion criteria | 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 |
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Target sample size | 80 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Cancer Institute Hospital Breast Cente | ||||||
Division name | Breast Oncology | ||||||
Zip code | |||||||
Address | 3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan | ||||||
TEL | 03-3520-0111 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | Cancer Institute Hospital Breast Center | ||||||
Division name | Breast Oncology | ||||||
Zip code | |||||||
Address | |||||||
TEL | |||||||
Homepage URL | |||||||
mmakita@jfcr.or.jp |
Sponsor | |
Institute | Cancer Institute Hospital Breast Center |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | Tokyo University of Pharmacy and Life Sciences, Department of Clinical Pharmacology |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | 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 |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005255 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |