Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast or Gynecological Cancer
QISEIN
1 other identifier
interventional
354
1 country
10
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Sep 2022
Typical duration for not_applicable breast-cancer
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2022
CompletedFirst Posted
Study publicly available on registry
February 15, 2022
CompletedStudy Start
First participant enrolled
September 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
October 1, 2024
September 1, 2024
4.9 years
February 3, 2022
September 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fatigue score change [min :5; max:20]
The difference between the initial (inclusion) score and the best score based on EORTC QLQ-FA12 questionnaire (physical fatigue dimension) between assessments at 1 week (S9) and 4 weeks (S12) after the end of treatment) will be calculated
After 1 week and 4 weeks after the end of treatment (so 8 weeks of treatment)
Secondary Outcomes (8)
Other dimensions of fatigue [min :12; max:48]
after 4 weeks of treatment, after 8 weeks of treatment and 4 weeks after the end of treatment
The incidence of treatment-related adverse events
up to 8 weeks after the end of treatment
Quality of life level assessed by EORTC QLQ-C30 questionnaire
4 and 8 weeks of treatment and 4 weeks after the end of treatment
anxiety level
after 4 and 8 weeks of treatment, and 4 weeks after the end of treatment
Cognitive function
after 4 and 8 weeks of treatment and 4 weeks after the end of treatment
- +3 more secondary outcomes
Study Arms (2)
Qiseng
EXPERIMENTAL200 mg/capsule of P. quinquefolius extract, i.e. 30 mg of ginsenosides, associated with 30 mg of vitamin C extracted from Camu Camu berry
Placebo
PLACEBO COMPARATORneutral microgranules of Qiseng® excipients without P. quinquefolius or Camu Camu extract
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify 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)
- Patients with chronic pain requiring daily treatment with analgesics, anti-inflammatory drugs or corticosteroids
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Francois Baclesselead
- NATSUCA laboratorycollaborator
- Groupement Interrégional de Recherche Clinique et d'Innovationcollaborator
Study Sites (10)
ARCOCEA_Clinique Europe
Amiens, France
Ch Bayeux
Bayeux, France
Centre Pierre Curie
Beuvry, France
Centre François Baclesse
Caen, France
Polyclinique du Parc
Caen, France
Ch Calais
Calais, France
Ch Cherbourg
Cherbourg, France
Clinique de Flandre
Coudekerque-Branche, France
Centre Henri Becquerel
Rouen, France
Clinique des Dentellières
Valenciennes, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2022
First Posted
February 15, 2022
Study Start
September 27, 2022
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
October 1, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share