Impact of American Ginseng on Fatigue in Breast or Gynecological Cancer Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Centre François Baclesse
  Caen, France Recruiting
• Ch Calais
  Calais, France Recruiting
• Clinique de Flandre
  Coudekerque-Branche, France Recruiting
• Centre Henri Becquerel
  Rouen, France Recruiting
• Clinique des Dentellières
  Valenciennes, France Recruiting
• ARCOCEA_Clinique Europe
  Amiens, France Not yet recruiting

Study contacts

• Study coordinator: Carine SEGURA, MD
• Email: c.segura@baclesse.unicancer.fr
• Phone: +33231455050

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.