Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Usual Care | Other | This arm receives usual-care only as cancer survivors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guarana herb | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to final visit (six weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to final visit (six weeks) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilmot Cancer Center | Rochester | New York | 14642 | United States |
The information is not yet available to determine whether IPD should be made available to other researchers or not.
Not provided
Not provided
Not provided
Not provided
Not provided
This is a three-arm study.
Not provided
Not provided
Not provided
Not provided
| Usual Care | Other | 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. |
|