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| ID | Type | Description | Link |
|---|---|---|---|
| T32CA102618 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fucoidan | Experimental | They will receive 4 grams daily of fucoidan extracted from F. Vesiculosus for 8 weeks. |
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| Usual Care | Active Comparator | They will receive usual care for 8 weeks followed by 4 grams daily of fucoidan extracted from U. Pinnatifida for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fucoidan extracted from F. Vesiculosus | Drug | 4 g daily |
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| Fucoidan extracted from U. Pinnatifida |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline to 16 weeks |
| mean change in plasma viscosity in blood |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeremy McGuire, PhD | Contact | 5852740472 | jeremy_mcguire@urmc.rochester.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Recruiting | Rochester | New York | 14642 | United States |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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| Drug |
4 g daily |
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| 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 | 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. | baseline to 16 weeks |