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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000011054
Receipt No. R000012930
Scientific Title Prospective observational study for the impact of short-term periodic intravenous steroid premedication for gastrointestinal cancer chemotherapy on bone metabolism.
Date of disclosure of the study information 2013/08/01
Last modified on 2018/02/17

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Basic information
Public title Prospective observational study for the impact of short-term periodic intravenous steroid premedication for gastrointestinal cancer chemotherapy on bone metabolism.
Acronym Evalutaion of the steroid premedication for cancer chemotherapy associated osteoporosis (ESPRESSO-01 study)
Scientific Title Prospective observational study for the impact of short-term periodic intravenous steroid premedication for gastrointestinal cancer chemotherapy on bone metabolism.
Scientific Title:Acronym Evalutaion of the steroid premedication for cancer chemotherapy associated osteoporosis (ESPRESSO-01 study)
Region
Japan

Condition
Condition Gastrointestinal cancer: Colorectal cancer, Non-colorectal cancer (Gastroesophageal, Pancreatic, and Biliary tract cancer)
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the impact of periodic intravenous steroids administrated as the premedication of chemotherapy on bone metabolism in patients with gastrointestinal cancers.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes To investigate the variations of bone mineral densities (DEXA) and bone turnover markers (NTX and BAP) between baseline and 16 weeks after.
Key secondary outcomes Comparing each groups of weekly, biweekly, and triweekly administrations of steroid.
The serum levels of albumin, calcium(Ca), phosphorus, fasting blood glucose, and creatinine(Cr), as well as urinary Ca and Cr measured on the indicated days: baseline, day 3, 7, 14, and 28
Site of a primary cancer
Regimens
Total amounts of steroids
Dose intensity of steroids
Newly bone fractures

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with histologically proven a gastrointestinal cancer including a pancreatic and a biliary duct cancer.
2) The duration of periodical intravenous steroid administration as premedication for prevention of nausea, vomitting, or allergic reaction due to chemotherapy is weekly, biweekly, and triweekly. More over 4 weeks steroid free intervals is not permissible.
3) Age 20 years or older
4) Written informed consent.
Key exclusion criteria 1) Take some steroids regularly already.
2) Take some bisphosphonates regularly already.
3) Take some calcium regularly already.
4) Regimens with steroid free interval over 4 weeks.
Target sample size 90

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Michio Nakamura
Organization Sapporo City General Hospital
Division name Dept. of Gastroenterology
Zip code
Address 1-1, Kita 11-jo, Nishi 13-Chome, Chuo-ku, Sapporo, JAPAN
TEL +81-11-726-2211
Email michio.nakamura@doc.city.sapporo.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Michio Nakamura
Organization Sapporo City General Hospital
Division name Dept. of gastroenterology
Zip code
Address 1-1, Kita 11-jo, Nishi 13-Chome, Chuo-ku, Sapporo, JAPAN
TEL +81-11-726-2211
Homepage URL
Email michio.nakamura@doc.city.sapporo.jp

Sponsor
Institute Hokkaido Gastrointestinal Cancer Study Group: HCGSC
Institute
Department

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
Address
Tel
Email

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 市立札幌病院

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 01 Day

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
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 Main results already published
Date of protocol fixation
2013 Year 05 Month 07 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 01 Day
Last follow-up date
2015 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design: Prospective observational study

Management information
Registered date
2013 Year 06 Month 27 Day
Last modified on
2018 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012930

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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