Cancer-related FatigueNCT03897556
Effect of High-Dose Guarana And Cancer-Related Fatigue
A study testing Guarana herb in people with Cancer-related Fatigue, run by University of Rochester at 1 site in United States.
Trial summary
This research will examine the effectiveness of a guaraná nutrition energy bar supplement on cancer-related fatigue based on scores from fatigue questionnaires. Participants will be randomized to one of three study arms: 1) two guaraná energy bars/day, 2) one guaraná energy bar/day 3) usual-care only/ no guaraná… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer-related Fatigue
- What is being tested?
- Guarana herb
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2019to 21 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Have a confirmed diagnosis of a malignant solid tumor between 4 and 36 months post-treatment (pathology report or MD documentation).
- Completed all forms of standard treatment (surgery, chemotherapy, radiation therapy, and/or immunotherapy) between 4 and 36 months prior to enrollment in the study.
- Be 18 years of age or older.
- Have cancer-related fatigue, as indicated by a response of a 4 or greater when asked to rate their level of fatigue at its worst in the past week on an 11-point scale anchored by "0": = 'no fatigue' and "10" = 'as bad as you can imagine' as taken from a single item question on the Symptom Inventory Questionnaire.
- Be able to read English (since the assessment materials are in printed format).
Who cannot join
- Participants must not: Have used guaraná supplements within the previous two months.
- Self-report that they are very sensitive to caffeine.
- Uncontrolled hypertension
- Have an allergy to walnuts, seaweed, soybeans and/or chocolate.
- Use medications for which caffeine intake is contraindicated including: β-adrenergic agonists, and/or medications that contain pseudoephedrine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of High-Dose Guaraná on Cancer-Related Fatigue in Cancer Survivors
This research will examine the effectiveness of a guaraná nutrition energy bar supplement on cancer-related fatigue based on scores from fatigue questionnaires. Participants will be randomized to one of three study arms: 1) two guaraná energy bars/day, 2) one guaraná energy bar/day 3) usual-care only/ no guaraná energy bars during study in cancer patients who have completed cancer treatment. We would also like to find out if this energy bar supplement improves physical performance, mood and reduces plasma glutamine and inflammation.
- Conditions
- Cancer-related Fatigue
- Being tested
- Guarana herb, Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guarana herbDietary supplement
The intervention is a functional food bar produced in a licensed commercial kitchen that contains guarana powder as well as dates, raisins, oats, spirulina, walnuts, flour, coconut butter, soybean oil, xanthan gum and chocolate chips.
Usual CareOther
Participant will receive 'usual-care' for cancer survivors. At the end of the study, after completing the Final Visit, they will receive 21 guarana energy bars to thank them for being in the study.
| Study group | Role | What they receive |
|---|---|---|
| High-dose | Active comparator | This arm consists of cancer survivors who receive two guarana energy bars to take per day for six weeks; one in the morning and one around lunch time. Receives: Dietary Supplement: Guarana herb |
| Low-Dose | Active comparator | This arm consists of cancer survivors who receive one guarana energy bar to take per day for six weeks; one in the morning only. Receives: Dietary Supplement: Guarana herb |
| Usual Care | Other | This arm receives usual-care only as cancer survivors. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in mean level of cancer-related fatigue based on the Brief Fatigue Inventory survey
Participant will complete the Brief Fatigue Inventory Survey at baseline, midpoint and the final assessments. The scale is an 11-point scale, with a higher value indicating worse or greater level of fatigue.
Measured: Baseline to final visit (six weeks)
Secondary outcomes (1)
The adherence to taking guarana energy bars: participant ate ≥ 80% of the guaraná energy bars assigned to them over the course of the study.
Participants will bring in any leftover bars they don't consume during the study at midpoint and final assessments.
Measured: Baseline to final visit (six weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start20 Oct 2019
- Primary completion20 Oct 2022
- Study completion21 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-related FatigueStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a three-arm study.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luke Peppone, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897556
- Sponsor's protocol ID
- 3607
- Status last verified
- Nov 2022
- First submitted
- 28 Mar 2019
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The information is not yet available to determine whether IPD should be made available to other researchers or not.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High-Dose Guaraná on Cancer-Related Fatigue in Cancer Survivors
- ClinicalTrials.gov ID
- NCT03897556
- Acronym / sponsor ID
- 3607
- Conditions
- Cancer-related Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 20 Oct 2019 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 21 Oct 2022 (actual)
- First posted
- 1 Apr 2019 (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.
This research will examine the effectiveness of a guaraná nutrition energy bar supplement on cancer-related fatigue based on scores from fatigue questionnaires. Participants will be randomized to one of three study arms: 1) two guaraná energy bars/day, 2) one guaraná energy bar/day 3) usual-care only/ no guaraná energy bars during study in cancer patients who have completed cancer treatment. We would also like to find out if this energy bar supplement improves physical performance, mood and reduces plasma glutamine and inflammation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a three-arm study.
| Arm | Type | Receives |
|---|---|---|
| High-dose | Active comparator | Dietary Supplement: Guarana herbThis arm consists of cancer survivors who receive two guarana energy bars to take per day for six weeks; one in the morning and one around lunch time. |
| Low-Dose | Active comparator | Dietary Supplement: Guarana herbThis arm consists of cancer survivors who receive one guarana energy bar to take per day for six weeks; one in the morning only. |
| Usual Care | Other | Other: Usual CareThis arm receives usual-care only as cancer survivors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have a confirmed diagnosis of a malignant solid tumor between 4 and 36 months post-treatment (pathology report or MD documentation).
- Completed all forms of standard treatment (surgery, chemotherapy, radiation therapy, and/or immunotherapy) between 4 and 36 months prior to enrollment in the study.
- Be 18 years of age or older.
- Have cancer-related fatigue, as indicated by a response of a 4 or greater when asked to rate their level of fatigue at its worst in the past week on an 11-point scale anchored by "0": = 'no fatigue' and "10" = 'as bad as you can imagine' as taken from a single item question on the Symptom Inventory Questionnaire.
- Be able to read English (since the assessment materials are in printed format).
Key exclusion criteria (5 listed)
- Participants must not: Have used guaraná supplements within the previous two months.
- Self-report that they are very sensitive to caffeine.
- Uncontrolled hypertension
- Have an allergy to walnuts, seaweed, soybeans and/or chocolate.
- Use medications for which caffeine intake is contraindicated including: β-adrenergic agonists, and/or medications that contain pseudoephedrine.
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 |
|---|---|---|
| Guarana herbThe intervention is a functional food bar produced in a licensed commercial kitchen that contains guarana powder as well as dates, raisins, oats, spirulina, walnuts, flour, coconut butter, soybean oil, xanthan gum and chocolate chips. | Dietary supplement | High-dose, Low-Dose |
| Usual CareParticipant will receive 'usual-care' for cancer survivors. At the end of the study, after completing the Final Visit, they will receive 21 guarana energy bars to thank them for being in the study. | Other | Usual Care |
Primary outcome
The change in mean level of cancer-related fatigue based on the Brief Fatigue Inventory survey
Time frame: Baseline to final visit (six weeks)
Participant will complete the Brief Fatigue Inventory Survey at baseline, midpoint and the final assessments. The scale is an 11-point scale, with a higher value indicating worse or greater level of fatigue.
1 secondary outcome
The adherence to taking guarana energy bars: participant ate ≥ 80% of the guaraná energy bars assigned to them over the course of the study.
Time frame: Baseline to final visit (six weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Individual participant dataSharing planned: Undecided. The information is not yet available to determine whether IPD should be made available to other researchers or not.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guarana herb in people with Cancer-related Fatigue, run by University of Rochester at 1 site in United States.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 9 Nov 2022. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in mean level of cancer-related fatigue based on the Brief Fatigue Inventory survey (time frame: Baseline to final visit (six weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2022.