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Clinical Trials in France / NCT05241405
Recruiting Not applicable

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

NCT05241405 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2022-09-27
Last updated
2024-10-01

Condition(s) studied

Breast CancerFatigue

Investigational drug(s) / intervention(s)

QISENGPLACEBO

QISENG: 2 capsules/day for 8 weeks.

PLACEBO: 2 capsules/day for 8 weeks.

Study summary

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

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05241405 on ClinicalTrials.gov ↗ ← All trials in France