Cancer-related fatigue (CRF) MedDRA version: 12.1 Level: LLT Classification code 10003549 Term: Asthenia
Conditions
Interventions
Product Name: panax ginseng
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: panax ginseng
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutica
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is the improvement of CRF, evaluated as the reduction of the score at the BFI scale.;Secondary Objective: Secondary objectives are the improvement of the quality of life, evaluated with the EQ5D scale, and the definition of the safety profile of Asiatic ginseng, evaluated with Common Terminology Criteria for adverse events (version 3.0).;Primary end point(s): Primary endpoint is the grade of fatigue evaluated with the BFI scale. | — |
Countries
Italy
Outcome results
None listed