Cancer-related FatigueGUARANA-CRFNCT07816263
Guaraná Supplementation for Cancer-Related Fatigue
An observational study of Cancer-related Fatigue and Breast Cancer, run by Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer-related Fatigue, Breast Cancer, Lung Cancer
- What is being tested?
- Guaraná (Paullinia cupana)
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteColombia
- Study dates
- 20 Jun 2026to 20 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with a histologic diagnosis of breast, lung, colorectal, cervical or gastric cancer who are receiving active systemic treatment at Fundación CTIC.
Who may be able to join
- Histologic diagnosis of breast, lung, colorectal, cervical or gastric cancer
- Receiving active cancer treatment
- Has completed at least three cycles of chemotherapy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
Fundación CTIC Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
Bogotá, Bogota D.C., 110131
Liliana Gutiérrez, RN, MSc, +573003768158, lgutierrez@fctic.org
Briegel De Las Salas, Microb, MSc, +573044921963, bcalderon@fctic.org
About this study
Official title: Evaluation of the Effectiveness of Guaraná (Paullinia Cupana) Supplementation in Reducing Cancer-Related Chronic Fatigue
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.
Read the 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.
- Conditions
- Cancer-related Fatigue, Breast Cancer, Lung Cancer, Colorectal Cancer, Gastric Cancer, Cervical Cancer
- Being tested
- Guaraná (Paullinia cupana)
- Keywords
- Guarana, Paullinia cupana, Cancer-related fatigue, Quality of life, Dietary supplement, Supportive care, Methylxanthines, Caffeine
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Guaraná (Paullinia cupana) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: Baseline, week 3, and end of treatment (up to 126 days)
Secondary outcomes (2)
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.
Measured: Baseline, week 3, and end of treatment (up to 126 days)
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.
Measured: Throughout treatment, up to 126 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start20 Jun 2026
- Primary completion18 Jan 2027 (estimated)
- Study completion20 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cancer-related FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrés F Cardona, MD, MSc, PhD, MBA, Study director, Fundación CTIC Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816263
- Sponsor's protocol ID
- Guarana
- Acronym
- GUARANA-CRF
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34146166Maselli-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.
PubMed 39536249de 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.
PubMed 21612429Berger 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.
PubMed 26285247
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Guaraná (Paullinia Cupana) Supplementation in Reducing Cancer-Related Chronic Fatigue
- ClinicalTrials.gov ID
- NCT07816263
- Acronym / sponsor ID
- GUARANA-CRF / Guarana
- Conditions
- Cancer-related Fatigue, Breast Cancer, Lung Cancer, Colorectal Cancer, Gastric Cancer, Cervical Cancer
- Keywords
- Guarana, Paullinia cupana, Cancer-related fatigue, Quality of life, Dietary supplement, Supportive care, Methylxanthines, Caffeine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento AnguloUniversity, hospital or other
- Study start
- 20 Jun 2026 (actual)
- Primary completion
- 18 Jan 2027 (estimated)
- Study completion
- 20 Jun 2027 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Guaraná supplementation cohort | – | Dietary Supplement: Guaraná (Paullinia cupana)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with a histologic diagnosis of breast, lung, colorectal, cervical or gastric cancer who are receiving active systemic treatment at Fundación CTIC.
Key inclusion criteria (3 listed)
- Histologic diagnosis of breast, lung, colorectal, cervical or gastric cancer
- Receiving active cancer treatment
- Has completed at least three cycles of chemotherapy
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guaraná (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. | Dietary supplement | Guaraná supplementation cohort |
Primary outcome
Change in cancer-related fatigue measured by FACIT-F (Functional Assessment of Chronic Illness Therapy - Fatigue)
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.
Change in fatigue measured by the Brief Fatigue Inventory (BFI)
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)
2 secondary outcomes
Change in quality of life measured by EORTC QLQ-C30
Time frame: Baseline, week 3, and end of treatment (up to 126 days)
Frequency and severity of adverse events (CTCAE v5.0)
Time frame: Throughout treatment, up to 126 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Background: PubMed 34146166de 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.
- Background: PubMed 39536249Maselli-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.
- Background: PubMed 21612429de 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.
- Background: PubMed 26285247Berger 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrés F Cardona, MD, MSc, PhD, MBA study director
Fundación CTIC Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer-related Fatigue and Breast Cancer, run by Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liliana Gutiérrez, RN, MSc (+573003768158, lgutierrez@fctic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cancer-related fatigue measured by FACIT-F (Functional Assessment of Chronic Illness Therapy - Fatigue) (time frame: Baseline, week 3, and end of treatment (up to 126 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07816263, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.