NCT Number: NCT07816263
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Bogotá, Bogota D.C., 110131, Colombia
Location status: Recruiting
Andrés F Cardona, MD, MSc, PhD, MBA
SUB_INVESTIGATOR
Briegel De Las Salas, Microb, MSc
CONTACT
Liliana Gutiérrez, RN, MSc
CONTACT
Liliana Gutiérrez, RN, MSc
PRINCIPAL_INVESTIGATOR
Background and rationale: Cancer-related fatigue affects 50-90% of patients across the disease trajectory and may persist for years after treatment. Its pathophysiology involves systemic inflammation, mitochondrial and skeletal-muscle dysfunction, oxidative stress, immune activation, and central-nervous-system involvement, with proinflammatory cytokines (IL-1, IL-6, TNF-α) contributing to symptom perpetuation. Available pharmacologic options (methylphenidate, modafinil, megestrol acetate) carry meaningful toxicity. Guaraná seeds contain 6-8% caffeine plus theophylline, theobromine, tannins, flavonoids and saponins, conferring stimulant, antioxidant and anti-inflammatory activity; prior trials and meta-analyses suggest benefit on fatigue with minimal toxicity, but results are inconsistent and ASCO/SIO have called for more rigorous trials.
Design: Pragmatic, prospective, single-arm study conducted in real-world clinical practice at a single center. Intervention: guaraná 50 mg capsule orally every 12 hours, 21 days per cycle, up to 6 cycles (total 126 days). Assessments at baseline, week 3, and end of treatment. Primary outcome: change in fatigue (FACIT-F and BFI). Secondary outcomes: quality of life (EORTC QLQ-C30), adverse events (CTCAE v5.0), and caregiver-perceived quality of life (proxy survey). Exploratory: adherence (capsule count, diary) and change in serum proinflammatory cytokines (IL-1, IL-6, TNF-α by ELISA) in a randomly selected subset of 30 participants (5 mL fasting venous blood at baseline, after 6-8 weeks, and at end of treatment; serum stored at -80 °C). Statistics: paired t-test or Wilcoxon for the pre-post change; multivariable regression adjusting for prespecified covariates; ITT with multiple imputation and per-protocol sensitivity analyses; α = 0.05 (two-sided), 80% power. Data captured in REDCap.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline, week 3, and end of treatment (up to 126 days)
Change in FACIT-F score from baseline to post-intervention. Higher scores indicate less fatigue.
Time frame: Baseline, week 3, and end of treatment (up to 126 days)
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)
Time frame: Baseline, week 3, and end of treatment (up to 126 days)
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.
Time frame: Throughout treatment, up to 126 days
Adverse events documented and graded per CTCAE v5.0, with attention to CNS stimulation (insomnia, palpitations, anxiety) and bleeding.
Time frame: Baseline, week 3, and end of treatment (up to 126 days)
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.
Time frame: Each cycle, up to 126 days
Adherence by capsule count and patient diary (e.g., proportion of prescribed capsules taken).
Time frame: Baseline, weeks 6-8, and at end of treatment (up to 126 days)
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.
Contact information is provided by the study sponsor or research team.
Briegel De Las Salas, Microb, MSc
CONTACT
Liliana Gutiérrez, RN, MSc
CONTACT
Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo
Other
Evaluation of the Effectiveness of Guaraná (Paullinia Cupana) Supplementation in Reducing Cancer-Related Chronic Fatigue
Acronym: GUARANA-CRF
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