JPRN-UMIN000023855
Completed
N/A
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) - Evaluation of the steroid premedication for cancer chemotherapy associated osteoporosis (ESPRESSO-02/HGCSG1602)
HGCSG (Hokkaido Gastrointestinal Cancer Study Group)0 sites45 target enrollmentDecember 1, 2016
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Gastrointestinal cancer: colorectal cancer, non-colorectal cancer (gastroesophageal, pancreatic, and biliary cancer)
- Sponsor
- HGCSG (Hokkaido Gastrointestinal Cancer Study Group)
- Enrollment
- 45
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •(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.
Outcomes
Primary Outcomes
Not specified
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