UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective observational study for the impact of short-term periodic intravenous steroid premedication for gastrointestinal cancer chemotherapy on bone metabolism.
Title of the study (Brief title)	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
Name of lead principal investigator	Michio Nakamura
Organization	Sapporo City General Hospital
Division name	Dept. of Gastroenterology
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
Name of contact person	Michio Nakamura
Organization	Sapporo City General Hospital
Division name	Dept. of gastroenterology
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 05 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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