Double-blind Randomized Multi-center Trial Regarding the Effects of Solution for Gemcitabine on Frequency and Degree of Vascular Pain in Patients with Cancer

UMIN ID: UMIN000001827

Registered date:31/03/2009

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-small-cell lung cancer, Bile duct cancer, Pancreatic cancer
• Date of first enrollment: 2009/03/01
• Target sample size: 90
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Patients with cancer are randomized to gemcitabine diluted with saline or 5% glucose solution at the first time after enrollment. Furthermore, those who are treated with gemcitabine diluted with saline at the first time will be treated with gemcitabine with 5% glucose solution at the next time by cross-over fashion.
Patients with cancer are randomized to gemcitabine diluted with saline or 5% glucose solution at the first time after enrollment. Furthermore, those who are treated with gemcitabine diluted with 5% of glucose solution at the first time will be treated with gemcitabine with saline solution at the next time by cross-over fashion.

Outcome(s)

• Primary Outcome: Frequency and degree of vascular pain
• Secondary Outcome: Adverse effects equal to or more than Grade 2 in CTCAEv3.0

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (1) Without active interstitial pneumonitis or uncontrollable lung fibrosis (2) No concurrent thoracic radiotherapy during chemotherapy; (3) Without uncontrollable infectious disease; (4) No severe complication including heart failure, renal insufficiency, liver dysfunction, hemorrhagic digestive tract ulcer, ileus, and uncontrollable diabetic mellitus (5) Without pregnancy or nurse (6) No uncontrollable mental disease (7) No inappropriate patient judged by a medical doctor for enrollment into this study

Related Information

• Primary Sponsor: Tohoku University Translational Research Center
• Secondary Sponsor: Tohoku University Hospital, Kyoto University Hospital
• Source(s) of Monetary Support: Ministry of Education, Science and Culture (19689018, and 17790524) of the Japanese government, and The Kanae Foundation for the Promotion of Medical Science