This is a multicenter randomized trial in breast cancer patients reporting cancer-related fatigue to evaluate the efficacy and safety of Qiseng® based on extract of American ginseng combined with vitamin C from extract of Camu Camu berries
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
354
ARCOCEA_Clinique Europe
Amiens, France
NOT_YET_RECRUITINGCh Bayeux
Bayeux, France
NOT_YET_RECRUITINGCentre Pierre Curie
Beuvry, France
Fatigue score change [min :5; max:20]
The difference between the initial (inclusion) score and the best score based on EORTC QLQ-FA12 questionnaire (physical fatigue dimension) between assessments at 1 week (S9) and 4 weeks (S12) after the end of treatment) will be calculated
Time frame: After 1 week and 4 weeks after the end of treatment (so 8 weeks of treatment)
Other dimensions of fatigue [min :12; max:48]
Score of emotional fatigue, cognitive fatigue, global score, according to the EORTC QLQ-FA12 self-questionnaire
Time frame: after 4 weeks of treatment, after 8 weeks of treatment and 4 weeks after the end of treatment
The incidence of treatment-related adverse events
The incidence of treatment-related adverse events and the number of patients in whom at least one treatment-related adverse event occurred
Time frame: up to 8 weeks after the end of treatment
Quality of life level assessed by EORTC QLQ-C30 questionnaire
EORTC QLQ-C30 quality of life questionnaire scores
Time frame: 4 and 8 weeks of treatment and 4 weeks after the end of treatment
anxiety level
HADS anxiety and depression questionnaire scores
Time frame: after 4 and 8 weeks of treatment, and 4 weeks after the end of treatment
Cognitive function
Cognitive function dimensions, according to the FACT-Cog self-assessment questionnaire,
Time frame: after 4 and 8 weeks of treatment and 4 weeks after the end of treatment
Physical activity level
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Centre François Baclesse
Caen, France
RECRUITINGPolyclinique du Parc
Caen, France
NOT_YET_RECRUITINGCh Calais
Calais, France
RECRUITINGCh Cherbourg
Cherbourg, France
NOT_YET_RECRUITINGClinique de Flandre
Coudekerque-Branche, France
RECRUITINGCentre Henri Becquerel
Rouen, France
RECRUITINGClinique des Dentellières
Valenciennes, France
RECRUITINGmeasured by the IPAQ questionnaire scores
Time frame: after 4 and 8 weeks of treatment, and again 4 weeks after the end of treatment
Sleep quality
measured by CAT-sleep questionnaire scores
Time frame: after 4 and 8 weeks of treatment and 4 weeks after the end of treatment
The level of acceptability of the treatment,
measured by the total number of times the treatment was taken
Time frame: over a period of 8 weeks