Actively Recruiting
Study of American Ginseng Combined with Vitamin C for 8 Weeks to Reduce Fatigue in Women Treated for Localized Breast or Gynecological Cancer
Led by Centre Francois Baclesse · Updated on 2024-10-01
354
Participants Needed
10
Research Sites
N/A
Total Duration
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
Research Team
C
Carine SEGURA, MD
A
Alexandra LECONTE
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