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
Centre Francois Baclesse
Lead sponsor
NATSUCA laboratory
Collaborator
Groupement Interrégional de Recherche Clinique et d'Innovation
Collaborator