Clinical Trial of the Seaweed Supplement Fucoidan in Survivors of Cancer

Not Applicable

Not yet recruiting

• Conditions: Fatigue; Inflammation
• Interventions: Dietary Supplement: Fucoidan extracted from F. Vesiculosus; Dietary Supplement: Fucoidan extracted from U. Pinnatifida

• Registration Number: NCT06295588
• Lead Sponsor: University of Rochester

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-28
• Study First Submitted QC: 2024-02-28
• Study First Posted: 2024-03-06
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-03
• Study Start: 2025-05-01
• Primary Completion: 2026-04-15
• Study Completion: 2026-04-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fucoidan	Fucoidan extracted from F. Vesiculosus	They will receive 4 grams daily of fucoidan extracted from F. Vesiculosus for 8 weeks.
Usual Care	Fucoidan extracted from U. Pinnatifida	They will receive usual care for 8 weeks followed by 4 grams daily of fucoidan extracted from U. Pinnatifida for 8 weeks.

Primary Outcome Measures

Name	Time	Method
percentage of participants who take at least 80% of the fucoidan pills during the study	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 are randomized to the study out of all participants approached	8 weeks

Secondary Outcome Measures

Name	Time	Method
mean change in C-reactive protein in blood	baseline to 16 weeks
mean change in neopterin in blood	baseline to 16 weeks
mean change in TNF alpha in blood	baseline to 16 weeks
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 lactase dehydrogenase 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.
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 thyroid stimulating hormone in blood	baseline to 16 weeks
mean change in leptin in blood	baseline to 16 weeks
mean change in procalcitonin in blood	baseline to 16 weeks
mean change in D Dimer in blood	baseline to 16 weeks

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States