Guaraná Supplementation for Cancer-Related Fatigue
NCT07816263
Summary
Cancer-related fatigue is one of the most common and distressing symptoms experienced by patients during and after cancer treatment, and current options to manage it are limited. Guaraná (Paullinia cupana), an Amazonian plant rich in caffeine and other methylxanthines with anti-inflammatory and central-nervous-system-stimulating properties, has shown preliminary benefit for fatigue in small studies but lacks robust evidence. This pragmatic, prospective, single-arm study will evaluate whether guaraná supplementation reduces chronic cancer-related fatigue and improves quality of life in 60 patients with breast, lung, colorectal, or gastric cancer receiving active systemic treatment. Participants will take a 50 mg guaraná capsule by mouth every 12 hours for up to six 21-day cycles. The main outcome is the change in fatigue (baseline vs. post-intervention) measured with the FACIT-F and the Brief Fatigue Inventory (BFI). Secondary outcomes include quality of life (EORTC QLQ-C30) and adverse events. The study aims to support guaraná as a safe, accessible complementary option in supportive cancer care.
Eligibility
Inclusion Criteria: * Histologic diagnosis of breast, lung, colorectal, cervical or gastric cancer * Receiving active cancer treatment * Has completed at least three cycles of chemotherapy Exclusion Criteria: * Intolerance to the oral route * Contraindications to guaraná intake * Uncontrolled cardiovascular disease (uncontrolled atrial fibrillation, symptomatic tachyarrhythmias, prolonged QT) * History of intolerance to caffeine, methylxanthines, or flavonoids * Use of CNS stimulants * Recent history of bleeding * Use of warfarin or any other vitamin K antagonist * Use of theophylline
Conditions8
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NCT07816263