NCT05241405 Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast or Gynecological Cancer
| NCT ID | NCT05241405 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Francois Baclesse |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 354 participants |
| Start Date | 2022-09-27 |
| Primary Completion | 2027-09 |
Trial Parameters
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Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * 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 * Effective contraception in women of childbearing age * Patient affiliated to a social security plan * Signed informed consent Exclusion Criteria: * Other identified causes of fatigue (anemia of grade \> 2, underlying chronic disease known to be associated with fatigue) * Ongoing chemotherapy (patients
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