Actively Recruiting
Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast or Gynecological Cancer
Led by Centre Francois Baclesse · Updated on 2024-10-01
354
Participants Needed
10
Research Sites
257 weeks
Total Duration
On this page
Sponsors
C
Centre Francois Baclesse
Lead Sponsor
N
NATSUCA laboratory
Collaborating Sponsor
AI-Summary
What this Trial Is 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
CONDITIONS
Official Title
Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast or Gynecological Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with localized breast or gynecological cancer treated with curative adjuvant and/or neoadjuvant chemotherapy and/or adjuvant radiotherapy completed within 6 months
- Chronic, stable fatigue with a score of 4 or higher on a 10-point scale lasting at least one month
- Allowed maintenance hormone or other therapies except pembrolizumab, abemaciclib, and PARP inhibitors
- Women aged 18 years or older
- Effective contraception for women of childbearing age
- Affiliated with a social security plan
- Signed informed consent
You will not qualify if you...
- Other causes of fatigue such as anemia grade > 2 or chronic diseases linked to fatigue
- Ongoing chemotherapy (except oral capecitabine or trastuzumab-emtasin in adjuvant setting)
- Metastatic breast or gynecological cancer
- Treatment with tyrosine kinase inhibitors, P-gp transported molecules, pembrolizumab, or PARP inhibitors
- Requirement for oral diabetes therapy
- Regular vitamin C intake beyond diet
- Chronic pain needing daily analgesics, anti-inflammatory drugs, or corticosteroids
- Use of ginseng products in the month before inclusion
- Hypersensitivity to Qiseng or placebo components
- Pregnant or breastfeeding
- Participation in other experimental therapeutic trials
- Legal restrictions such as deprivation of liberty, guardianship, or curatorship
- Inability to follow medical monitoring due to geographical, social, or psychological reasons
- History of malignant disease in last 3 years except certain skin and uterine cancers and treated solid tumors or lymphomas without recurrence for at least 3 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
ARCOCEA_Clinique Europe
Amiens, France
Not Yet Recruiting
2
Ch Bayeux
Bayeux, France
Not Yet Recruiting
3
Centre Pierre Curie
Beuvry, France
Not Yet Recruiting
4
Centre François Baclesse
Caen, France
Actively Recruiting
5
Polyclinique du Parc
Caen, France
Not Yet Recruiting
6
Ch Calais
Calais, France
Actively Recruiting
7
Ch Cherbourg
Cherbourg, France
Not Yet Recruiting
8
Clinique de Flandre
Coudekerque-Branche, France
Actively Recruiting
9
Centre Henri Becquerel
Rouen, France
Actively Recruiting
10
Clinique des Dentellières
Valenciennes, France
Actively Recruiting
Research Team
C
Carine SEGURA, MD
CONTACT
A
Alexandra LECONTE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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