NCT07816263

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Jun 2026Jun 2027

Study Start

First participant enrolled

June 20, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 30, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 11, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2027

Last Updated

September 11, 2026

Status Verified

July 1, 2026

Enrollment Period

7 months

First QC Date

July 30, 2026

Last Update Submit

September 9, 2026

Conditions

Cancer-related FatigueBreast CancerLung CancerColorectal CancerGastric CancerCervical CancerQuality of Life

Keywords

GuaranaPaullinia cupanaCancer-related fatigueQuality of lifeDietary supplementSupportive careMethylxanthinesCaffeine

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline, week 3, and end of treatment (up to 126 days)

  • 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)

    Baseline, week 3, and end of treatment (up to 126 days)

Secondary Outcomes (2)

  • Change in quality of life measured by EORTC QLQ-C30

    Baseline, week 3, and end of treatment (up to 126 days)

  • Frequency and severity of adverse events (CTCAE v5.0)

    Throughout treatment, up to 126 days

Other Outcomes (3)

  • Change in caregiver-perceived patient quality of life measured by a caregiver proxy adaptation of the EORTC QLQ-C30

    Baseline, week 3, and end of treatment (up to 126 days)

  • Adherence to guaraná supplementation

    Each cycle, up to 126 days

  • Change in serum proinflammatory cytokines (IL-1β, IL-6, TNF-α) in a subset of participants (n=30)

    Baseline, weeks 6-8, and at end of treatment (up to 126 days)

Study Arms (1)

Guaraná supplementation cohort

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.

Dietary Supplement: Guaraná (Paullinia cupana)

Interventions

Guaraná (Paullinia cupana)DIETARY_SUPPLEMENT

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.

Guaraná supplementation cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with a histologic diagnosis of breast, lung, colorectal, cervical or gastric cancer who are receiving active systemic treatment at Fundación CTIC.

You may qualify if:

  • Histologic diagnosis of breast, lung, colorectal, cervical or gastric cancer
  • Receiving active cancer treatment
  • Has completed at least three cycles of chemotherapy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundación CTIC Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo

Bogotá, Bogota D.C., 110131, Colombia

RECRUITING

Related Publications (4)

  • de 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: 34146166BACKGROUND

  • Maselli-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: 39536249BACKGROUND

  • de 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: 21612429BACKGROUND

  • Berger 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: 26285247BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum from venous blood (5 mL fasting) for cytokine analysis (IL-1, IL-6, TNF-α by ELISA) in a randomly selected subset of 30 participants; collected at baseline, after 6-8 weeks, and at end of treatment; stored at -80 °C.

MeSH Terms

Conditions

Breast NeoplasmsLung NeoplasmsColorectal NeoplasmsStomach NeoplasmsUterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesStomach DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Andrés F Cardona, MD, MSc, PhD, MBA

    Fundación CTIC Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo

    STUDY DIRECTOR

Central Study Contacts

Liliana Gutiérrez, RN, MSc

CONTACT

+573003768158lgutierrez@fctic.org

Briegel De Las Salas, Microb, MSc

CONTACT

+573044921963bcalderon@fctic.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2026

First Posted

September 11, 2026

Study Start

June 20, 2026

Primary Completion (Estimated)

January 18, 2027

Study Completion (Estimated)

June 20, 2027

Last Updated

September 11, 2026

Record last verified: 2026-07

Locations

CO(1)