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.
Histologic diagnosis of breast, lung, colorectal, cervical or gastric cancer
Receiving active cancer treatment
Has completed at least three cycles of chemotherapy
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
Adults with a histologic diagnosis of breast, lung, colorectal, cervical or gastric cancer who are receiving active systemic treatment at Fundación CTIC.
Cohort
Prospective
Guaraná (Paullinia cupana)
Dietary supplementGuaraná 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.
Change in cancer-related fatigue measured by FACIT-F (Functional Assessment of Chronic Illness Therapy - Fatigue)
Change in FACIT-F score from baseline to post-intervention. Higher scores indicate less fatigue.
Change in fatigue measured by the Brief Fatigue Inventory (BFI)
Brief Fatigue Inventory (BFI). Change from baseline in the BFI global fatigue score, calculated as the mean of all 9 items. Each item is rated on a 0-10 numeric scale. Severity subscale = mean of items 1-3 (range 0-10; 0 = no fatigue, 10 = as bad as you can imagine). Interference subscale = mean of items 4-9 (range 0-10; 0 = does not interfere, 10 = completely interferes). Higher scores indicate worse fatigue (worse outcome)
Change in quality of life measured by EORTC QLQ-C30
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQC-30, version 3.0). Change from baseline in the global health status/QoL scale and in functional and symptom scales. All raw scores are linearly transformed to a 0-100 range. For the global health status/QoL and functional scales, higher scores indicate better outcome; for symptom scales/items, higher scores indicate worse outcome.
Frequency and severity of adverse events (CTCAE v5.0)
Adverse events documented and graded per CTCAE v5.0, with attention to CNS stimulation (insomnia, palpitations, anxiety) and bleeding.
Change in caregiver-perceived patient quality of life measured by a caregiver proxy adaptation of the EORTC QLQ-C30
Change from baseline in the caregiver's perception of the patient's quality of life, assessed with a caregiver proxy adaptation of the EORTC QLQ-C30, version 3.0, in which the 30 original items are reworded so that the patient's primary caregiver rates the patient rather than the patient self-reporting. Items 1-28 are rated on a 4-point scale (1 = not at all, 4 = very much) and items 29-30 on a 7-point scale (1 = very poor, 7 = excellent). Items are grouped into one global health status/quality of life scale, five functional scales (physical, role, emotional, cognitive, social) and nine symptom scales/single items, and scored using the standard EORTC scoring procedure: the raw score for each scale is the mean of its component items, linearly transformed to a 0-100 range.Higher scores on the global health status/quality of life and functional scales indicate better perceived quality of life; higher scores on symptom scales indicate worse perceived symptom burden.
Adherence to guaraná supplementation
Adherence by capsule count and patient diary (e.g., proportion of prescribed capsules taken).
Change in serum proinflammatory cytokines (IL-1β, IL-6, TNF-α) in a subset of participants (n=30)
Change from baseline in serum concentrations of interleukin-1 beta (IL-1β), interleukin-6 (IL-6) and tumor necrosis factor alpha (TNF-α), measured by \[ELISA/multiplex immunoassay\] and reported in pg/mL, in a prespecified subset of 30 participants.
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