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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 354 participants in total. It began in 2022-09-27 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 * Patient requiring oral diabetes therapy * Regular intake of Vitamin C (in addition to what is provided by the diet) * Patients with chronic pain requiring daily treatment with analgesics, anti-inflammatory drugs or corticosteroids * Consumption of ginseng-based products in the month prior to inclusion * Hypersensitivity to any of the components of Qiseng or placebo * Pregnant or breastfeeding patient * Simultaneous participation in another therapeutic clinical trial (trial using an experimental product) * Patient deprived of liberty, under guardianship or curatorship * Patient unable to undergo the medical follow-up of the trial for geographical, social or psychopathological reasons * History of any other malignant disease during the last 3 years, except for skin cancer other than melanoma, carcinoma in situ of the uterus. Any other solid tumor or lymphoma (without bone marrow involvement) must have been treated and show no signs of recurrence for at least 3 years
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05241405 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05241405 currently recruiting?
Yes, NCT05241405 is actively recruiting participants. Contact the research team at c.segura@baclesse.unicancer.fr for enrollment information.
Where is the NCT05241405 trial being conducted?
This trial is being conducted at Amiens, France, Bayeux, France, Beuvry, France, Caen, France and 6 additional locations.
Who is sponsoring the NCT05241405 clinical trial?
NCT05241405 is sponsored by Centre Francois Baclesse. The trial plans to enroll 354 participants.
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