A multicenter prospective study on the efficacy and safety of denosumab in gastrointestinal cancer patients receiving short-term periodic steroid premedication of chemotherapy-induced nausea and vomiting (ESPRESSO-02/HGCSG1602)
- Conditions
- Gastrointestinal cancer: colorectal cancer, non-colorectal cancer (gastroesophageal, pancreatic, and biliary cancer)
- Registration Number
- JPRN-UMIN000023855
- Lead Sponsor
- HGCSG (Hokkaido Gastrointestinal Cancer Study Group)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 45
Not provided
(1) Current regular use of steroids. (2) Current regular use of bisphosphonates or other drugs that affect the skeleton. (3) Regimens with steroid free interval >4-weeks. (4) Patients who cannot do the examination for DXA (5) Past radiation therapy for the evaluation lesion of DXA (6) Past total or partial gastrectomy (7) Serum calcium levels < 8.0 mg/dL (8) On going dental interventional treatment. (9) Renal dysfunction (serum creatinine levels: over 1.5 mg/dL) (10) Other concurrent active cancer (synchronous double cancer or heterochronous double cancer with a disease-free interval of 5 years or shorter,excluding colorectal cancer, lesions consistent with intraepithelial cancer, i.e., carcinoma in situ, or intramucosal cancer that are assessed as cured by local treatment). (11) Premenopausal, pregnant, breast-feeding, possibly pregnant women or patients wishing to have children. (12) Accumulation of pleural, ascitic, or pericardial fluid requiring drainage (13) Active bleeding (14) No prior operation for gastrointestinal tract within 28 day except proctostomy. (15) Current or past severe lung disease (e.g. interstitial pneumonia, pulmonary fibrosis, or severe emphysema). (16) Any other active illness such as severe cardiac disease (e.g. myocardial infarction, angina pectoris, arrhythmia, or cardiac failure). Any of the following events within the 6 months prior to enrollment. (17) Serious hypersensitivity to any ingredients of denosumab. (18) Active infection and/or inflammatory diseases. (19) Severe cardiac failure (over NYHA II) (20) Ineligible for participating in this study according to the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate the efficacy of denosumab for preventing a bone mineral density reduction 16 weeks after induction of chemotherapy.
- Secondary Outcome Measures
Name Time Method The incidence of hypocalcemia and jawbone necrosis 16 weeks after initiation of chemotherapy. The variation of bone turnover markers (serum BAP and NTX) 16 weeks after initiation of chemotherapy. The serum levels of albumin, calcium(Ca), phosphorus, creatinine(Cr), alkaline phosphatase(ALP), fasting blood glucose, serum intact PTH, serum TSH, serum FT3, serum FT4, and HbA1c as well as urinary Ca and Cr measured on the indicated days: baseline, day 7, 14, 28, and 16 weeks. Subgroup analysis for ECOG PS,Primary site, treatment schedule (weekly, biweekly, and triweekly), total amounts of steroids, and sex. Newly bone fractures and bone metastasis Safety JOQOL and FRAX.