UMIN-CTR Clinical Trial

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

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

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Hokkaido Gastrointestinal Cancer Study Group: HCGSC

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

市立札幌病院

Date of disclosure of the study information

2013

Year

08

Month

01

Day

URL releasing protocol

Publication of results

Published

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

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 related information

Study design: Prospective observational study

Registered date

2013

Year

06

Month

27

Day

Last modified on

2018

Year

02

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012930