Impact of American Ginseng on Fatigue in Breast or Gynecological Cancer Patients
Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast or Gynecological Cancer - Randomized, Placebo-controlled, Double-blind Study
This study is testing if a supplement made from American ginseng and vitamin C can help breast or gynecological cancer patients who feel tired after their treatment feel less fatigued.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 354 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Centre Francois Baclesse Academic / other |
| Drugs / interventions | trastuzumab, bevacizumab, pembrolizumab, chemotherapy |
| Locations | 10 sites (Amiens and 9 other locations) |
| Trial ID | NCT05241405 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized trial evaluates the efficacy and safety of Qiseng®, an extract of American ginseng combined with vitamin C from Camu Camu berries, in patients with localized breast or gynecological cancer experiencing cancer-related fatigue. Participants must have completed their curative chemotherapy or radiotherapy within the last six months and report stable fatigue. The study compares the effects of Qiseng® against a placebo over an 8-week period. The goal is to determine if this supplement can alleviate fatigue symptoms in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with localized breast or gynecological cancer who have completed curative treatment and report chronic fatigue.
Not a fit: Patients with other identified causes of fatigue or those currently undergoing chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, effective option for managing fatigue in cancer patients.
How similar studies have performed: While the specific combination of American ginseng and vitamin C is novel, previous studies have shown potential benefits of ginseng in reducing fatigue in cancer patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amiens and 9 other locations
- ARCOCEA_Clinique Europe — Amiens, France (Not_yet_recruiting)
- Ch Bayeux — Bayeux, France (Not_yet_recruiting)
- Centre Pierre Curie — Beuvry, France (Not_yet_recruiting)
- Centre François Baclesse — Caen, France (Recruiting)
- Polyclinique du Parc — Caen, France (Not_yet_recruiting)
- Ch Calais — Calais, France (Recruiting)
- Ch Cherbourg — Cherbourg, France (Not_yet_recruiting)
- Clinique de Flandre — Coudekerque-Branche, France (Recruiting)
- Centre Henri Becquerel — Rouen, France (Recruiting)
- Clinique des Dentellières — Valenciennes, France (Recruiting)
Study contacts
- Study coordinator: Carine SEGURA, MD
- Email: c.segura@baclesse.unicancer.fr
- Phone: +33231455050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.