UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010939 |
|---|---|
| Receipt number | R000012802 |
| Scientific Title | Androgen replacement therapy for hypogonadism in advanced cancer patients |
| Date of disclosure of the study information | 2013/06/12 |
| Last modified on | 2021/06/30 09:01:12 |
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Basic information
Public title
Androgen replacement therapy for hypogonadism in advanced cancer patients
Acronym
ART for advanced cancer patients
Scientific Title
Androgen replacement therapy for hypogonadism in advanced cancer patients
Scientific Title:Acronym
ART for advanced cancer patients
Region
| Japan |
Condition
Condition
hypogonadism in avanced cancer
Classification by specialty
| Hematology and clinical oncology | Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will clarify the efficacy of androgen replacement therapy for diverse symptoms caused by hypogonadism in advanced cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of QOL beween control group and ART group
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Enarmon depot intramuscular injection 250mg a month
Interventions/Control_2
control
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1. male
2. pathologically diagnosed as cancer or sarcoma
3. no aplication for radical treatment because of locally advanced or metastatic disease
4. patients know their diagnosis and status
5. obtained informed concent by document
6. normal cardiovascular, hepatic and renal function, and AST(GOT) and ALT(GPT):<3.0 times of institutional upper limit, BUN:<30mg/dL, and Cr:<3.0mg/dL
Key exclusion criteria
1. lrss than 20 year-old
2. prostate cancer or severe BPH
3. PSA>4ng/ml
and patients who were thought as inadequate for this study by doctor in charge
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Mizokami |
Organization
Kanazawa University
Division name
Department of Urology
Zip code
920-8641
Address
13-1 Takaramachi, Kanazawa
TEL
0762652393
azuizu2003@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kouji |
| Middle name | |
| Last name | Izumi |
Organization
the Institutional Review Board of Kanazawa University
Division name
Department of Urology
Zip code
920-8641
Address
13-1 Takaramachi, Kanazawa
TEL
0762652019
Homepage URL
azuizu2003@yahoo.co.jp
Sponsor or person
Institute
Kanazawa University, Department of Urology
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Institutional Review Board of Kanazawa University
Address
13-1 Takaramachi, Kanazawa
Tel
0762652019
azuizu2003@yahoo.co.jp
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
| 2013 | Year | 06 | Month | 12 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1002/jcsm.12716
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/jcsm.12716
Number of participants that the trial has enrolled
106
Results
The numbers of patients in the control and testosterone groups were 41 and 40, respectively. The testosterone group showed significant improvement in the unhappiness item of the Edmonton Symptom Assessment System at weeks 8 and 12. Serum tumor necrotic factor-alpha in the control group was significantly increased at week 12.
Results date posted
| 2021 | Year | 06 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Male cancer patients with low serum testosterone levels
Participant flow
Participants were randomly assigned to the control group or the testosterone enanthate administration group.
Adverse events
Grade 3 (Common Terminology Criteria for Adverse Events v4.0) of aspartate transaminase increase and alanine transaminase increase was observed in one patient.
Outcome measures
Differences in quality of life questionnaires and cachexia-related serum protein levels between groups were assessed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2013 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 12 | Day |
Last modified on
| 2021 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012802
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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