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Official title Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast or Gynecological Cancer
ClinicalTrials.gov ID: NCT05241405
What this study is testing
- What it's testing
- 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
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Patients with localized breast or gynecological cancer treated as curative adjuvant and/or neoadjuvant chemotherapy and/or adjuvant radiotherapy...
- Patient reporting a chronic, stable fatigue state at investigator assessment, defined as a fatigue score ≥ 4 on the visual analog scale rated up to...
- Maintenance therapy with hormone therapy or other maintenance therapy (trastuzumab, bevacizumab…) is allowed before and/or during the study (except...
- Patient 18 years of age or older
- Effective contraception in women of childbearing age
You likely can't join if
- 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)
See the full eligibility 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...
- Patient 18 years of age or older
- Effective contraception in women of childbearing age
- Patient affiliated to a social security plan
- Signed informed consent
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Bayeux, France
- Beuvry, France
- Caen, France
- Calais, France
- Cherbourg, France
- Coudekerque-Branche, France
- Rouen, France
- Valenciennes, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Bayeux, France; Beuvry, France; Caen, France; Calais, France; Cherbourg, France and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.