Clinical trial · Observational
Guaraná Supplementation for Cancer-Related Fatigue
Evaluation of the Effectiveness of Guaraná (Paullinia Cupana) Supplementation in Reducing Cancer-Related Chronic Fatigue
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer-related Fatigue | — | UNRESOLVED | — |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Guaraná (Paullinia cupana) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Guaraná supplementation cohort
- description
- Adults with histologically confirmed breast, lung, colorectal, cervical or gastric cancer on active systemic treatment, receiving guaraná supplementation and followed prospectively for change in fatigue and quality of life.
- interventionNames
- Dietary Supplement: Guaraná (Paullinia cupana)
Primary outcomes (2)
- measure
- Change in cancer-related fatigue measured by FACIT-F (Functional Assessment of Chronic Illness Therapy - Fatigue)
- timeFrame
- Baseline, week 3, and end of treatment (up to 126 days)
- description
- Change in FACIT-F score from baseline to post-intervention. Higher scores indicate less fatigue.
- measure
- Change in fatigue measured by the Brief Fatigue Inventory (BFI)
- timeFrame
- Baseline, week 3, and end of treatment (up to 126 days)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDde Araujo DP, Pereira PTVT, Fontes AJC, Marques KDS, de Moraes EB, Guerra RNM, Garcia JBS. The use of guarana (Paullinia cupana) as a dietary supplement for fatigue in cancer patients: a systematic review with a meta-analysis. Support Care Cancer. 2021 Dec;29(12):7171-7182. doi: 10.1007/s00520-021-06242-5. Epub 2021 Jun 19. PMID 34146166
- BACKGROUNDMaselli-Schoueri JH, Aguiar Junior PN, Giglio AD. Natural supplementation to effectively treat cancer-induced fatigue: evidence of a meta-analysis on the use of guarana. Rev Assoc Med Bras (1992). 2024 Nov 11;70(10):e20240528. doi: 10.1590/1806-9282.20240528. eCollection 2024. PMID 39536249
- BACKGROUNDde Oliveira Campos MP, Riechelmann R, Martins LC, Hassan BJ, Casa FB, Del Giglio A. Guarana (Paullinia cupana) improves fatigue in breast cancer patients undergoing systemic chemotherapy. J Altern Complement Med. 2011 Jun;17(6):505-12. doi: 10.1089/acm.2010.0571. Epub 2011 May 25. PMID 21612429
- BACKGROUNDBerger AM, Mooney K, Alvarez-Perez A, Breitbart WS, Carpenter KM, Cella D, Cleeland C, Dotan E, Eisenberger MA, Escalante CP, Jacobsen PB, Jankowski C, LeBlanc T, Ligibel JA, Loggers ET, Mandrell B, Murphy BA, Palesh O, Pirl WF, Plaxe SC, Riba MB, Rugo HS, Salvador C, Wagner LI, Wagner-Johnston ND, Zachariah FJ, Bergman MA, Smith C; National comprehensive cancer network. Cancer-Related Fatigue, Version 2.2015. J Natl Compr Canc Netw. 2015 Aug;13(8):1012-39. doi: 10.6004/jnccn.2015.0122. PMID 26285247