Guarana for Fatigue in Cancer Patients

Overseen By Erin Ward, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Utah

Must be taking: Somatostatin analogs, Platinum-based chemotherapy

Must not be taking: Psychostimulants, β-adrenergic agonists

Disqualifiers: Hypothyroidism, Autoimmune disease, Caffeine sensitivity, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

86 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if guarana, a natural plant known for its energy-boosting effects, can reduce fatigue in people with neuroendocrine tumors or gynecologic cancers. Participants will receive either guarana or a placebo to assess any noticeable difference in energy levels. It suits those who feel exhausted despite current treatment, have these specific cancer types, and are not using guarana or sensitive to caffeine. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to potentially improve their energy levels.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot take certain medications like psychostimulants or those containing pseudoephedrine. If you're on these, a washout period (time without taking these medications) is required before starting the trial.

Is there any evidence suggesting that guarana is likely to be safe for humans?

A previous study found that guarana did not reduce cancer-related fatigue more effectively than a placebo, which is a fake treatment. Another review also concluded that guarana was not more effective than a placebo, and the evidence was weak. However, some other research suggests guarana might help with fatigue in cancer patients, but more studies are needed.

Regarding safety, guarana is a plant-based supplement often found in energy drinks and diet products, so most people can use it without problems. However, like any treatment, some people might experience side effects such as a faster heartbeat or trouble sleeping. It's important to consult your doctor to determine if guarana is right for you. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for fatigue?

Unlike the standard treatments for fatigue in cancer patients, which often include medications like psychostimulants and antidepressants, Guarana offers a natural alternative derived from a plant native to the Amazon. Researchers are excited because Guarana contains caffeine and other stimulating compounds that may boost energy levels without the side effects associated with conventional pharmaceuticals. This could provide a more holistic option for managing fatigue, appealing to patients seeking natural remedies. Additionally, Guarana’s potential benefits are being explored in a clinical setting, which could lead to a better understanding of its effectiveness and optimal use.

What evidence suggests that guarana might be an effective treatment for fatigue in cancer patients?

Research has shown that guarana might help reduce tiredness in cancer patients. A review of several studies supports using guarana for cancer-related fatigue. In this trial, participants will receive either guarana or a placebo to determine its effect on fatigue symptoms. One study focused on patients tired from chemotherapy and found that guarana helped lessen their tiredness. Another study found guarana to be a safe and effective option for breast cancer patients experiencing fatigue from radiation. These findings suggest guarana could be helpful for those feeling tired from various cancer treatments. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with neuroendocrine tumors or gynecologic cancers who are experiencing fatigue. Specific eligibility criteria details were not provided, so it's important to contact the study organizers for more information on who can participate.

Inclusion Criteria

Documentation of a score of 4 or higher when answering either of the NCCN-recommended screening questions within 4 weeks prior to randomization

Able to provide informed consent and willing to sign an approved consent form

I am 18 years old or older.

Exclusion Criteria

History of significant autoimmune disease likely to impact study participation

Known HIV infection with a detectable viral load within 6 months of the anticipated start of treatment

Known hypersensitivity or allergy to investigational product

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive guarana or placebo to assess its effect on fatigue symptoms

6 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Guarana

Trial Overview The trial is testing whether guarana, a plant that may have stimulating effects, can reduce fatigue in patients compared to a placebo (a substance with no active drug). Participants will be randomly assigned to receive either guarana or the placebo.

How Is the Trial Designed?

Group I: Guarana Experimental Treatment 1 Intervention

The study's goal is to determine the effect of Guarana on symptoms of fatigue

Group II: Placebo Placebo Group 1 Intervention

The study's goal is to determine the effect of Guarana on symptoms of fatigue

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11554322/

evidence of a meta-analysis on the use of guaraná CONCLUSION: This meta-analysis provides support for the use of guaraná in the treatment of cancer-related fatigue. However, further ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e24087

Evidence from a meta-analysis on the use of guarana. Conclusions: Our analysis supports the use of Guarana to combat Cancer-Related Fatigue. Further investigation with prospective randomized ...

3. clinicaloncologyletters.com clinicaloncologyletters.com/article/10.4322/col.2018.007/pdf/col-3-1-2-53.pdf

Paullinia cupana (Guarana) for Chemotherapy-Induced ... This meta-analysis of 3 randomized clinical trials, including 134 patients, evaluated the efficacy of Paullinia cupana in reducing the fatigue intensity in ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00615316?term=AREA%5BInterventionSearch%5D(Paullinia)&rank=3

Guaraná for Radiation Related Fatigue in Breast Cancer ... We hypothesize that Guaraná, a native plant from the Amazon, might improve radiation-induced fatigue in breast cancer patients undergoing treatment. In order to ...

5. liebertpub.com liebertpub.com/doi/10.1089/acm.2010.0571

Guarana (Paullinia cupana) Improves Fatigue in Breast ... Conclusions: Guarana is an effective, inexpensive, and nontoxic alternative for the short-term treatment of fatigue in BC patients receiving ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34146166/

The use of guarana (Paullinia cupana) as a dietary ... The use of guarana did not reduce cancer-related fatigue compared with placebo groups (mean of - 0.02 [95% CI - 1.54, 1.50]; p = 0.98) and the ...

7. mskcc.org mskcc.org/cancer-care/integrative-medicine/herbs/guarana

Guarana A meta-analysis also concluded that guarana was not superior to placebo for cancer-related fatigue and that evidence was of low quality. Further ...