Recruiting

Guaraná Supplementation for Cancer-Related Fatigue

ClinicalTrials.gov IDNCT07816263

PhaseNot Applicable

Enrollment60

SponsorCentro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo

Age18 Years and older

SexALL

I'm interested View official listing

Conditions studied

Cancer-related Fatigue, Breast Cancer, Lung Cancer, Colorectal Cancer, Gastric Cancer, Cervical Cancer, Quality of Life

About this study

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.

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.

Primary outcomes

Change in cancer-related fatigue measured by FACIT-F (Functional Assessment of Chronic Illness Therapy - Fatigue) (Baseline, week 3, and end of treatment (up to 126 days))
Change in fatigue measured by the Brief Fatigue Inventory (BFI) (Baseline, week 3, and end of treatment (up to 126 days))

Eligibility information

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

Study locations

Fundación CTIC Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo, Bogotá, Bogota D.C. 110131 Colombia

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-22.