E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cancer-related fatigue (CRF) |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003549 |
E.1.2 | Term | Asthenia |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is the improvement of CRF, evaluated as the reduction of the score at the BFI scale. |
|
E.2.2 | Secondary objectives of the trial |
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). |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
|
E.4 | Principal 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 |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint is the grade of fatigue evaluated with the BFI scale. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
- same IMP used at different dosage |
|
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LPLV= Last patient last treatment |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |