Breast Cancer, Cancer-related Fatigue, Cervical Cancer, Colorectal Cancer, Gastric Cancer, Lung Cancer, Quality of Life
Conditions
Keywords
Guarana, Paullinia cupana, Cancer-related fatigue, Quality of life, Dietary supplement, Supportive care, Methylxanthines, Caffeine
Brief 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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTGuaraná (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.
Sponsors
Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 FACIT-F score from baseline to post-intervention. Higher scores indicate less fatigue. |
| Change in fatigue measured by the Brief Fatigue Inventory (BFI) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life measured by EORTC QLQ-C30 | 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. |
| Frequency and severity of adverse events (CTCAE v5.0) | 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. |
Countries
Colombia
Contacts
CONTACTLiliana Gutiérrez, RN, MSc
CONTACTBriegel De Las Salas, Microb, MSc
STUDY_DIRECTORAndrés F Cardona, MD, MSc, PhD, MBA
Fundación CTIC Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
Outcome results
None listed