Fatigue, Inflammation
Conditions
Keywords
cancer-related fatigue
Brief summary
To determine the feasibility of an 8-week fucoidan supplement intervention for patients with fatigue post-cancer treatment and assess changes in fatigue, frailty, and inflammation.
Interventions
4 g daily
DRUGFucoidan extracted from U. Pinnatifida
4 g daily
Sponsors
University of Rochester
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Survivors of cancer * Age 18 or older * Speak and understand English * Have completed surgery, radiation, and/or systemic intravenous anticancer therapy (e.g., chemotherapy, targeted therapy, immunotherapy) ≤10 years prior to enrollment. * Have a baseline level of fatigue, as determined by reporting a score of 4 or higher for the question, "In the last week, how bad was your worst fatigue on a scale from 0-10?" * Be willing to commit to the fucoidan supplement dosing and delivery method, to complete evaluation instruments, and to attend all study visits. * Completed Informed Consent
Exclusion criteria
* Current warfarin or other anti-coagulation medication use. * Current use of supplements that contain fucoidan * Any allergy to fucoidan * Be diagnosed with a major psychiatric illness requiring hospitalization within the last year. * Be diagnosed with dementia. * Be pregnant or nursing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percentage of participants who are randomized to the study out of all participants approached | 8 weeks |
| percentage of participants who start the intervention who go on to complete the 8-week or 16-week intervention | 16 weeks |
| percentage of participants who take at least 80% of the fucoidan pills during the study | 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mean change in Brief Fatigue Inventory | baseline to 16 weeks | The Brief Fatigue Inventory is a 9-item questionnaire that ranges from 0 to 10 with higher scores indicating a worse outcome. |
| mean change in plasma viscosity in blood | baseline to 16 weeks | — |
| mean change in erythrocyte sedimentation rate in blood | baseline to 16 weeks | — |
| mean change in thyroid stimulating hormone in blood | baseline to 16 weeks | — |
| mean change in C-reactive protein in blood | baseline to 16 weeks | — |
| mean change in leptin in blood | baseline to 16 weeks | — |
| mean change in D Dimer in blood | baseline to 16 weeks | — |
| mean change in TNF alpha in blood | baseline to 16 weeks | — |
| mean change in neopterin in blood | baseline to 16 weeks | — |
| mean change in lactase dehydrogenase in blood | baseline to 16 weeks | — |
| mean change in procalcitonin in blood | baseline to 16 weeks | — |
| mean change in frailty using a modified Fried's Frailty questionnaire | baseline to 16 weeks | The modified Fried's Frailty questionnaire measures self-reported slowness, weakness, weight loss, physical activity and fatigue. The total score of the questionnaire ranges from 1 to 5 with higher numbers indicating worse outcome. |
Countries
United States
Outcome results
None listed