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Prospective observational study for the impact of short-term periodic intravenous steroid premedication for gastrointestinal cancer chemotherapy on bone metabolism.

Prospective observational study for the impact of short-term periodic intravenous steroid premedication for gastrointestinal cancer chemotherapy on bone metabolism. - Evalutaion of the steroid premedication for cancer chemotherapy associated osteoporosis (ESPRESSO-01 study)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000011054
Enrollment
90
Registered
2013-08-01
Start date
2013-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal cancer: Colorectal cancer, Non-colorectal cancer (Gastroesophageal, Pancreatic, and Biliary tract cancer)

Interventions

None listed

Sponsors

Hokkaido Gastrointestinal Cancer Study Group: HCGSC
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
To investigate the variations of bone mineral densities (DEXA) and bone turnover markers (NTX and BAP) between baseline and 16 weeks after.

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactMichio Nakamura

Sapporo City General Hospital Dept. of gastroenterology

michio.nakamura@doc.city.sapporo.jp+81-11-726-2211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026