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

Centre Francois Baclesse

Status: Enrolling

Conditions: Breast Cancer; Fatigue

Treatments: Dietary Supplement: QISENG; Dietary Supplement: PLACEBO

Study type: Interventional

Funder types: Other

Identifiers

NCT05241405

2021-A01550-41

Details and patient eligibility

About

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

Enrollment: 354 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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354 participants in 2 patient groups, including a placebo group

Qiseng

Experimental group

Description:

200 mg/capsule of P. quinquefolius extract, i.e. 30 mg of ginsenosides, associated with 30 mg of vitamin C extracted from Camu Camu berry

Treatment:

Dietary Supplement: QISENG

Placebo

Placebo Comparator group

Description:

neutral microgranules of Qiseng® excipients without P. quinquefolius or Camu Camu extract

Treatment:

Dietary Supplement: PLACEBO