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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
4 g daily
4 g daily
University of Rochester Medical Center
Rochester, New York, United States
percentage of participants who are randomized to the study out of all participants approached
Time frame: 8 weeks
percentage of participants who start the intervention who go on to complete the 8-week or 16-week intervention
Time frame: 16 weeks
percentage of participants who take at least 80% of the fucoidan pills during the study
Time frame: 8 weeks
mean change in Brief Fatigue Inventory
The Brief Fatigue Inventory is a 9-item questionnaire that ranges from 0 to 10 with higher scores indicating a worse outcome.
Time frame: baseline to 16 weeks
mean change in plasma viscosity in blood
Time frame: baseline to 16 weeks
mean change in erythrocyte sedimentation rate in blood
Time frame: baseline to 16 weeks
mean change in thyroid stimulating hormone in blood
Time frame: baseline to 16 weeks
mean change in C-reactive protein in blood
Time frame: baseline to 16 weeks
mean change in leptin in blood
Time frame: baseline to 16 weeks
mean change in D Dimer in blood
Time frame: baseline to 16 weeks
mean change in TNF alpha in blood
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Time frame: baseline to 16 weeks
mean change in neopterin in blood
Time frame: baseline to 16 weeks
mean change in lactase dehydrogenase in blood
Time frame: baseline to 16 weeks
mean change in procalcitonin in blood
Time frame: baseline to 16 weeks
mean change in frailty using a modified Fried's Frailty questionnaire
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.
Time frame: baseline to 16 weeks