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Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast or Gynecological Cancer

RecruitingNAAges 18 Years - anyFemaleCentre Francois Baclesse
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • QISENG
  • PLACEBO
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Where

10 sites
ARCOCEA_Clinique Europe
Amiens, France
Ch Bayeux
Bayeux, France
Centre Pierre Curie
Beuvry, France
Centre François Baclesse
Caen, France
Polyclinique du Parc
Caen, France
Ch Calais
Calais, France
Ch Cherbourg
Cherbourg, France
Clinique de Flandre
Coudekerque-Branche, France

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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