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
Patients with localized breast or gynecological cancer treated as curative adjuvant and/or neoadjuvant chemotherapy and/or adjuvant radiotherapy. These treatments must have been completed within 6 months of inclusion.
Patient reporting a chronic, stable fatigue state at investigator assessment, defined as a fatigue score ≥ 4 on the visual analog scale rated up to 10, experienced for at least one month
Maintenance therapy with hormone therapy or other maintenance therapy (trastuzumab, bevacizumab…) is allowed before and/or during the study (except for pembrolizumab, abemaciclib and PARP inhibitors, which are not authorized)
Patient 18 years of age or older
Other identified causes of fatigue (anemia of grade > 2, underlying chronic disease known to be associated with fatigue)
Ongoing chemotherapy (patients scheduled for oral capecitabine or trastuzumab-emtasin in the adjuvant setting are not eligible)
Metastatic breast or gynecological cancer
Ongoing treatment with a tyrosine kinase inhibitor or other P-gp transported molecule or Pembrolizumab or PARP inhibitors
Parallel
QISENG
Dietary supplement2 capsules/day for 8 weeks.
PLACEBO
Dietary supplement2 capsules/day for 8 weeks.
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
Other dimensions of fatigue [min :12; max:48]
Score of emotional fatigue, cognitive fatigue, global score, according to the EORTC QLQ-FA12 self-questionnaire
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
Quality of life level assessed by EORTC QLQ-C30 questionnaire
EORTC QLQ-C30 quality of life questionnaire scores
anxiety level
HADS anxiety and depression questionnaire scores
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Centre Francois Baclesse
Lead sponsor
NATSUCA laboratory
Collaborator
Groupement Interrégional de Recherche Clinique et d'Innovation
Collaborator
