Actively Recruiting
Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast or Gynecological Cancer - Randomized, Placebo-controlled, Double-blind Study
Led by Centre Francois Baclesse · Updated on 2024-10-01
354
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Centre Francois Baclesse
Lead Sponsor
N
NATSUCA laboratory
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of American ginseng combined with vitamin C from Camu Camu berries on fatigue in patients treated for localized breast or gynecological cancer. This multicenter randomized trial aims to assess the safety and efficacy of the dietary supplement Qiseng in improving cancer-related fatigue. The study is randomized, double-blind, and placebo-controlled, led by the Centre Francois Baclesse. Participants receive either Qiseng, containing 200 mg of P. quinquefolius extract 30 mg ginsenosides plus 30 mg vitamin C, or a placebo made of microgranules without active extracts. Both groups take 2 capsules daily for 8 weeks. The trial includes detailed monitoring of fatigue and other quality-of-life aspects during and after treatment. During the study, participants will have their fatigue levels assessed after 1 week and 4 weeks following the 8-week treatment. Researchers will also evaluate other fatigue dimensions, treatment-related side effects, quality of life, anxiety, cognitive function, physical activity, sleep quality, and treatment acceptability at multiple timepoints. The study spans approximately 12 weeks with close follow-up for safety and outcome measurement.
CONDITIONS
Brief 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 of inclusion
- Reporting chronic, stable fatigue with a score of 4 or more on a visual analog scale of 10, lasting at least one month
- Allowed maintenance therapy with hormone therapy or other maintenance therapy except pembrolizumab, abemaciclib, and PARP inhibitors
- Female patients 18 years or older
- Effective contraception in women of childbearing age
- Affiliated to a social security plan
- Signed informed consent
You will not qualify if you...
- Other identified causes of fatigue such as anemia grade > 2 or chronic diseases linked to fatigue
- Ongoing chemotherapy or scheduled oral capecitabine or trastuzumab-emtasin in adjuvant setting
- Metastatic breast or gynecological cancer
- Ongoing treatment with tyrosine kinase inhibitors, P-gp transported molecules, pembrolizumab, or PARP inhibitors
- Requirement of oral diabetes therapy
- Regular intake of Vitamin C supplements beyond diet
- Chronic pain needing daily analgesics, anti-inflammatory drugs, or corticosteroids
- Consumption of ginseng-based products in the month before inclusion
- Hypersensitivity to Qiseng or placebo components
- Pregnant or breastfeeding
- Participation in another therapeutic clinical trial
- Legal guardianship or custody
- Unable to comply with medical follow-up for geographic, social, or psychological reasons
- History of other malignant diseases within 3 years except certain skin cancers and treated tumors with no recurrence for at least 3 years
Research Team
C
Carine SEGURA, MD
A
Alexandra LECONTE
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