Clinical effects of azasetoron / dexamethasone combination-therapy on the prevention of nausea and vomiting caused by chemotherapy treatment for colon cancer patients - Comparative cross-over trial between azasetoron single-therapy and azasetoron/dexamethasone combination-therapy -

UMIN ID: C000000406

Registered date:17/04/2006

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: colon cancer
• Date of first enrollment: 2006/04/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

drip-infusion of azasetoron (10mg/body) before the administration of anti-cancer agents (day1)
drip-infusion of azasetoron (10mg/body) and dexamethason (8mg/body) before the administration of anti-cancer agents (day1)

Outcome(s)

• Primary Outcome: inhibition rate of vomiting events
• Secondary Outcome: vomiting frequency, score of nausea, patient's feelings (anti-emesis, appetite)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: Patients to receive surgical treatment or irradiation treatment during the term of this study Patients who develop complications of severe cardiovascular disease, hemodyscrasia, renal disease or hepatic disease. Pregnant or lactating women Patients with a history of hypersensitivity to any of the drugs used in this study.

Related Information

• Primary Sponsor: Yokohama City University Graduate School of Medicine
• Source(s) of Monetary Support: Yokohama City University Graduate School of Medicine