GATAC: Asian ginseng (Panax Ginseng) for the treatment of Cancer-Related Fatigue: a randomized, double-blind controlled study. - gatac

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI0 个研究点开始时间: 2010年5月21日最近更新: 2012年4月3日

试验速览

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•Patient with a median fatigue score superior or egual 4 with BFI
•Patient who belong to one of the following groups:
•1)patients who finished an adjuvant chemotherapy for breast cancer, or colo-rectal cancer or ovarian cancer or lung cancer and with no evidence of disease
•2)patients with metastatic cancer, progressive after a first line that must begin a second or third line
•3)patients with progressive advanced cancer, no more eligible for chemotherapy
•Patient with life expectancy superior 6 month
•Patient with Performance Status 0-1
•Patient who have signed Informed Consent
•Patient older than 18 years old
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Patient with anemia (hb inferior 9g) or hypothyroidism uncompensated with therapy or with persistent insomnia
•Patient with diabetes in treatment with oral hypoglycaemic and/or insulin
•Patient in treatment with Warfarin and with history of bleeding
•Patient who begun an anxiolytic therapy from less that 2 month or anxiolytic therapy with a unstabilized dosage
•Patient who will undergo radiotherapy or surgical procedures
•Patient who already use commercial products with ginseng
•Patient who inconstant use supplements
•Patient with arterial hypertension not controlled by drugs
•Patient with history of acute asthma
•Patient who are not able to swallow capsules
•Pregnant or breast-feeding woman
•Fertile woman who refuse appropriate contraceptive

发起方

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI