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RECRUITING
NCT07816263

Guaraná Supplementation for Cancer-Related Fatigue

Sponsor: Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo

View on ClinicalTrials.gov

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.

Official title: Evaluation of the Effectiveness of Guaraná (Paullinia Cupana) Supplementation in Reducing Cancer-Related Chronic Fatigue

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2026-06-20

Completion Date

2027-06-20

Last Updated

2026-09-11

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Guaraná (Paullinia cupana)

Guaraná 50 mg capsule administered orally every 12 hours, 21 days per cycle, for up to 6 cycles (total 126 days). Manufactured by INVIMA-certified suppliers; stored under controlled conditions. Adherence monitored by capsule count plus patient diary; adverse events graded with CTCAE v5.0.

Locations (1)

Fundación CTIC Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo

Bogotá, Bogota D.C., Colombia